Post-vaccination Symptoms Research Articles

Vaccine hesitancy in the post-vaccination COVID-19 era: a machine learning and statistical analysis driven study.

Background The COVID-19 pandemic has badly affected people of all ages globally. Therefore, its vaccine has been developed and made available for public use in unprecedented times. However, because of various levels of hesitancy, it did not have general acceptance. The main objective of this work is to identify the risk associated with the COVID-19 vaccines by developing a prognosis tool that will help in enhancing its acceptability and therefore, reducing the lethality of SARS-CoV-2. Methods: The obtained raw VAERS dataset has three files indicating medical history, vaccination status, and post vaccination symptoms respectively with more than 354 thousand samples. After pre-processing, this raw dataset has been merged into one with 85 different attributes however, the whole analysis has been subdivided into three scenarios ((i) medical history (ii) reaction of vaccination (iii) combination of both). Further, Machine Learning (ML) models which includes Linear Regression (LR), Random Forest (RF), Naive Bayes (NB), Light Gradient Boosting Algorithm (LGBM), and Multilayer feed-forward perceptron (MLP) have been employed to predict the most probable outcome and their performance has been evaluated based on various performance parameters. Also, the chi-square (statistical), LR, RF, and LGBM have been utilized to estimate the most probable attribute in the dataset that resulted in death, hospitalization, and COVID-19. Results: For the above mentioned scenarios, all the models estimates different attributes (such as cardiac arrest, Cancer, Hyperlipidemia, Kidney Disease, Diabetes, Atrial Fibrillation, Dementia, Thyroid, etc.) for death, hospitalization, and COVID-19 even after vaccination. Further, for prediction, LGBM outperforms all the other developed models in most of the scenarios whereas, LR, RF, NB, and MLP perform satisfactorily in patches. Conclusion: The male population in the age group of 50–70 has been found most susceptible to this virus. Also, people with existing serious illnesses have been found most vulnerable. Therefore, they must be vaccinated in close observations. Generally, no serious adverse effect of the vaccine has been observed therefore, people must vaccinate themselves without any hesitation at the earliest. Also, the model developed using LGBM establishes its supremacy over all the other prediction models. Therefore, it can be very helpful for the policymakers in administrating and prioritizing the population for the different vaccination programs.

Relationship between changes in symptoms and antibody titers after a single vaccination in patients with Long COVID.

Coronavirus disease 2019 (COVID‐19) is spreading worldwide; there is a need to address its sequelae known as Long COVID. This study evaluated postvaccination changes in symptoms and antibody titers in patients with Long COVID. Patients visiting the outpatient department specializing in Long COVID at our hospital were enrolled. Changes in symptoms were evaluated before and 14–21 days after first vaccination. Antibody titers were measured using ARCHITECT SARS‐CoV‐2 IgG II Quant at the same time. This study included 42 patients (median age: 45 years; 17 [40.5%] men). Median pre‐ and postvaccination antibody titers were 456 and 28,963 AU/ml, respectively. Postvaccination symptoms (fatigue, joint pain, and taste and olfactory abnormalities) were relieved, worsened, and unchanged in 7 (16.7%), 9 (21.4%), and 26 (61.9%) patients, respectively. Ratios of pre‐ and postvaccination antibody titers were 53, 40, and 174 in the unchanged, relief, and worsened groups, respectively. The worsened group had the significantly highest antibody titer ratio (p = 0.02). The higher increased rate of the antibody titer in the worsened group than in the nonworsened group suggests an excessive immune response to vaccination associated with worsening of sequelae. Although patients with Long COVID should be vaccinated, additional concerns should be addressed.

A Study on Post Vaccination Symptoms after First and Second Dose of vaccine in Western UP and Delhi NCR.

The aim of this Study was to analyze the post vaccination symptoms after first & second dose of vaccine in Western UP and Delhi NCR. The study was conducted on the individual who have been administered either single or double dose of currently approved and Indian vaccine namely Covaxin and Covishield. It is found that vaccinated individuals are protected against symptomatic COVID-19 infection and severe progression. Internet has played an important role in our lives during the last decades and provides us information about twothird of world population at a single click. The current study was designed taking the advent of internet. The major criteria and parameters for the present study includes centre of vaccine administration, occupation of the participants besides the age and sex were also considered.

Post Vaccination Symptoms among I Dose Covid-19 Vaccinated Adults in Puducherry

Abstract: The aim was to understand the prevalence of post COVID-19 (COVISHIELD) vaccination symptoms among I dose COVID-19 vaccinated adults in Puducherry through a descriptive study and analyze the association with epidemiologic factors. 100 participants were selected according to the inclusion and exclusion criteria by systematic random sampling technique. A descriptive research design was used for the study. Data was collected using symptom questionnaire among the participants at PHC Mudaliarpet, Puducherry between the age group of 19-70 years. Data analysis was done using descriptive statistics and inferential statistics. Out of the 100 samples majority, 36 (36%) of study population were in the age group of above 50 years whereas 57 (57%) were male and 48 (48%) had no co-morbidity. The overall results of the study shows that 68 (68%) had fatigue, 41 (41%) had fever, 33 (33%) ad pain at the injection site, 26 (26%) had malaise, 9 (9%) had headache, 7 (7%) had nausea and vomiting, 4 (4%) had diarrhoea and 3 (3%) had chills. The demographic variables age have shown statistically significant association with nausea and vomiting among the selected participants with chi-square value of  2 =7.941 (d.f=3) at p<0.05 level. The study concluded stating that fatigue is the most commonly prevailing post COVID-19 vaccination symptom among I dose COVID-19 vaccinated adults. Keywords: COVID-19 Vaccination, Side effects, Symptoms

Evaluating the Factors Affecting the Occurrence of Symptomatic COVID-19 Illness after Vaccination

Background: Vaccination against COVID-19 illness is mainstay of undertaking the pandemic. However, it has been frequently observed that many patients developed COVID-19 illness after vaccination. Aim: To find out the factors other than the “mere chance” affecting the development of COVID-19 illness after vaccination so to identify high risk population and to suggest modify their vaccinations accordingly. Study design: Descriptive, retrospective cohort study Place and duration of study: Falahee Foundation Clinics of Shifa International Hospital, Islamabad from 1st February 2021 to 31st July 2021. Methodology: Sixty health care workers (HCW) who got vaccinated were enrolled. Results: 34 (58.6%) were male and 26 (41.4%) were females with mean age of 42±8.3 years. Twenty (33.3%) HCWs developed post vaccination symptoms, 12 of them got their COVID-19 PCR done. Seven (58.33%) had positive PCR and 5 (41.66%)had negative PCR. Female gender and co-morbid conditions affected the post vaccination symptoms and positivity of PCR significantly. Conclusion: Female gender, hypothyroidism, hypertension and celiac disease patients proved high risk for vaccination in our limited cohort. So co-morbid condition need consideration regarding further inquiry and necessary vaccination modifications. Keywords: Factors, Co-morbid, Post-vaccination

Motivational Factors and Post Vaccination Symptoms among COVID-19 Vaccinated Beneficiaries at a Tertiary Care Hospital, West Bengal, India: A Cross-sectional Study

Introduction: Since the emergence of Coronavirus Disease 2019 (COVID-19) pandemic, there has been an intense burden on the health system and economy worldwide with millions of people being affected leading to several deaths. In this scenario vaccination seems to be a hope to control the pandemic. However, fear of adverse events following immunisation sometimes makes people hesitant about vaccination. Aim: To assess the spectrum of post vaccination symptoms and also to identify the motivational factors along with their determinants at a tertiary care hospital, West Bengal, India. Materials and Methods: A cross-sectional study was conducted in the COVID-19 Vaccination Centre at Nil Ratan Sircar Medical College and Hospital, Kolkata West Bengal, India (tertiary care hospital), from August 2021 to November 2021. A total of 448 vaccinated beneficiaries were enrolled in the study. Data collection was done by an online questionnaire, sent to the participants in their registered mobile numbers. Descriptive statistics and Chisquare tests were used for data analysis. Results: Among 448 study participants, 262 (58.5%) were in 18- 44 years of age group, 248(55.4%) female, 384 (85.7%) Hindu, 132 (29.5%) medical or paramedical students, 290 (64.7%) passed graduation and above and 306 (68.3%) belonged to nuclear family. About 228 (50.9%) beneficiaries reported post vaccination symptoms. Most common being local pain at injection site, found among 150 (65.8%) out of them. Most common motivational factors of COVID-19 vaccination were found to be fear of COVID-19 infection, reported by 274 (61.2%) participants, which showed significant difference with various age groups (p-value=0.001), religions (p-value=0.030), occupations (p-value<0.001) and educations (p-value=0.002). Statistical significant (p<0.05) differences were also found according to age, gender, co-morbidities, interval between vaccination and past COVID-19 infection and type of COVID-19 vaccine in relation to onset of post vaccination symptoms. Conclusion: Following COVID-19 immunisation minor adverse events were reported. Monitoring of those adverse events will help in further responding and prompt action. Also, the knowledge about motivational factors is expected to reduce vaccine hesitancy among unvaccinated people.

EVALUATION OF COVID-19 VACCINES EFFICACY IN IRAQI PEOPLES.

The aim: The present study was carried out on patients recovered from COVID-19, including those patients who have taken vaccine and those who have not. Materials and methods: The patients were recruited via an online panel and surveyed at different regions of Iraq from June 1, 2021, to August 30, 2021. Results: Our results demonstrated that the highest percentage of people recommended Pfizer vaccine followed by Sinopharm, while AstraZeneca vaccine was least recommended. Conclusions: The efficacy of different vaccines differed significantly; the highest effectiveness was observed with Pfizer vaccine followed by AstraZeneca and Sinopharm with effectiveness ranging from 94%, 89%, and 74%, respectively. Further, the highest percentage of re-infected patients was observed with Sinopharm vaccine followed by Astra Zeneca and Pfizer vaccine, respectively. Also, the highest percent of re-infection with masking used was seen in the case of Sinopharm vaccine followed by AstraZeneca and Pfizer vaccine. Although, we observed that post-vaccination symptoms were lowest than pre-vaccination symptoms, the percent of asymptomatic cases post-vaccination was highest than pre-vaccination cases for all vaccines.

Online survey for symptoms following COVID-19 postvaccination in Karnataka: A cross-sectional study

Background: While the protective efficacy of vaccine is frequently discussed, little is known about the real-world postvaccination experience outside of clinical trial conditions. The objective of the study was to assess the immediate response to the first and second dose of COVID-19 vaccine and to study the spectrum of postvaccination symptom profile for individuals' vaccines. Materials and Methods: A cross-sectional online survey was done using Google Forms. It was circulated via electronic media to the people who had taken COVID-19 vaccine from July 1 to July 30, 2021. Data were analyzed using SPSS version 20.00. Results: A total of 610 people responded to the online survey. Majority (29%) of respondents belonged to the 20–30 years' age group, followed by 30–40 years' age group (24%). The respondents were predominantly males (82%) and belonging to urban area (57%). Almost 57% of the people had taken Covishield, with the rest having received Covaxin. About 53% of the people had taken the first dose of vaccine. The respondents reported postvaccination symptoms as follows: fever (56%), muscle pain (47%), headache (45%), redness (35%), tiredness (33%), itching (30%), joint pain (30%), and swelling (27%). A total of 45% of participants experienced some health problems and 69% had taken medications after vaccination to relieve the symptoms. A statistically significant association was observed between first dose of COVID-19 vaccine and gender of the participants (P = 0.0024). A similar association was also observed between the dose of COVID-19 vaccine and presence of postvaccination symptoms, namely, fever (P = 0.0001), headache (P = 0.0001), muscle pain (P = 0.0010), tiredness (P = 0.029), breathlessness (P = 0.001), and joint pains (P = 0.012). Conclusion: Post-COVID vaccination symptoms are very common in the community irrespective of age and gender.

EVALUATION OF COVID-19 VACCINES EFFICACY IN IRAQI PEOPLES

The aim: The present study was carried out on patients recovered from COVID-19, including those patients who have taken vaccine and those who have not. Materials and methods: The patients were recruited via an online panel and surveyed at different regions of Iraq from June 1, 2021, to August 30, 2021. Results: Our results demonstrated that the highest percentage of people recommended Pfizer vaccine followed by Sinopharm, while AstraZeneca vaccine was least recommended. Conclusions: The efficacy of different vaccines differed significantly; the highest effectiveness was observed with Pfizer vaccine followed by AstraZeneca and Sinopharm with effectiveness ranging from 94%, 89%, and 74%, respectively. Further, the highest percentage of re-infected patients was observed with Sinopharm vaccine followed by Astra Zeneca and Pfizer vaccine, respectively. Also, the highest percent of re-infection with masking used was seen in the case of Sinopharm vaccine followed by AstraZeneca and Pfizer vaccine. Although, we observed that post-vaccination symptoms were lowest than pre-vaccination symptoms, the percent of asymptomatic cases post-vaccination was highest than pre-vaccination cases for all vaccines.

Evaluation of Post-Vaccination Signs and Symptoms Among Iranian Health Professionals Vaccinated by Different Types of COVID-19 Vaccine

Evaluation of Post-Vaccination Signs and Symptoms Among Iranian Health Professionals Vaccinated by Different Types of COVID-19 Vaccine

Determination of Spectrum of Symptoms Observed Followed by Administration of 1st and 2nd Doses of COVISHIELD™ Vaccine in Datta Meghe Institute of Medical Sciences (Deemed to be University) – A Study Protocol

Background: The 2019 novel coronavirus (2019-nCoV or SARS-CoV-2) was first detected in December 2019 in Wuhan City of Hubei, Province of China with population of 11 million, after outbreak of pneumonia. Present study deals with acceptability of newly manufactured vaccines against Covid 19 disease component of social misconceptions regarding the post vaccination symptoms and/or adverse events. Main rationale of this study is to list all post vaccination symptoms observed at multiple points of time to clear misconceptions resulting in possible increase in acceptability of newer vaccines.
 Aim: To determine the spectrum of symptoms observed followed by administration of 1st and 2nd doses of COVISHIELD™ vaccine in Datta Meghe Institute of Medical Sciences (deemed to be university).
 Methods: This will be a Prospective analytical cohort study conducted over a period of 5 years. 
 Procedure: Followed by letter of informed consent, pre validated questionnaire will be circulated amongst the healthcare professionals having been administered the 1st and 2nd doses of COVISHIELD™ vaccine filled and submitted to authorized email for further study and will be evaluated for enlisting post vaccination symptoms with time of onset and duration following 1st and 2nd doses of COVISHIELD™ vaccine. Follow up will maintained at regular intervals and questionnaire will be amongst participants at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after the 2nd dose of COVISHIELD™ vaccine.
 Expected Outcome: Post vaccination symptoms following 1st and 2nd doses of COVISHIELD™ vaccine with range of time of onset and duration of the same will enhance status of the COVISHIELD™ vaccine awareness, social acceptability and willingness.
 Conclusion: All conclusions will be drawn after proper statistical analysis.

Assessment of Post-Vaccination Antibody Response Eight Months after the Administration of BNT1622b2 Vaccine to Healthcare Workers with Particular Emphasis on the Impact of Previous COVID-19 Infection.

At the end of 2020, COVID-19 vaccination programs were initiated in many countries, including Poland. The first vaccine approved in Poland was the BNT162b2 mRNA preparation (Pfizer/BioNTech), and the first vaccinated group were healthcare workers. The aim of the present study was to evaluate post-vaccine antibody titers 8 months after the second vaccine dose had been administered to a group of employees of the Hospital of the Ministry of the Interior and Administration in Olsztyn (Poland). The employees were divided into two groups: persons who had COVID-19 in the fourth quarter of 2020 and were vaccinated in January–February 2021, and persons without a history of COVID-19 who were vaccinated during the same period. The analyzed material was venous blood serum collected from 100 hospital employees on 23–28 September 2021. The level of anti-SARS-CoV-2 S antibodies was measured with a Roche Cobas e411 analyzer using the electrochemiluminescence (ECLIA) method. The study demonstrated that persons with a history of SARS-CoV-2 infection had significantly higher antibody levels (taking into account gender, age, type of work performed, and severity of post-vaccination symptoms) than employees without a history of COVID-19. The study also revealed that the type of work, age, gender, and the course of SARS-CoV-2 infection can influence the humoral immune response. The presented results may prove helpful in the context of administering additional vaccine doses.

Assessment of Post Vaccination Symptoms Following COVID-19 Vaccination in India: A Cross-Sectional Descriptive Study

Introduction: The recent examples of newly emerged diseases that causes alarming situation globally include H1N1, Congo Hemorrhagic fever, Ebola virus diseases, Nipah Virus Infection, Lassa Fever and newly declared global emergency pandemic SARS nCOVID-19 infection. Since its emergence, it has spread around the globe. It tends to spread by the inhalation of the respiratory aerosols, direct human contact.
 Materials and Methods: This analytical study was carried out among the healthcare workers and people who received either of Covishield or Covaxin. The online survey questionnaire was prepared and data obtained through the responses to the survey proforma.
 Results: 86.17% respondents were above 40 years, 69.15% males and 30.85% were females. 89.36% were vaccinated with Covishield and 10.64% by Covaxin. 75.53% respondents experienced post vaccination symptoms; commonest were the local pain at injection site (28.72%), fever (12.76%), Myalgia (12.77%). The symptoms were found more in respondents with any of co-morbid condition.
 Discussion: Covishield was used more commonly than Covaxin in study samples. The symptoms following vaccination were more common in 40-60 age group and persons with co-morbid conditions.

A CROSS-SECTIONAL STUDY ON ACCEPTANCE AND POST-VACCINATION SYMPTOMS OF COVID-19 VACCINATION IN INDIA

Objectives: The fastidious development of the COVID-19 vaccine is a vital achievement for the country and early data suggest that it is both safe and efficacious, however, the acceptance of the COVID-19 vaccine is still a major concern as it depends on the individual decision and sociodemographic characteristics. The main objective of our study is to assess the vaccine acceptance among Indians and study about post-vaccination symptoms to identify potential concerns to be addressed to ensure vaccine safety. Methods: An online cross-sectional study was conducted using Google Forms over a period of 1 week on the general population. Data were collected which included the questions regarding participant demographics, vaccination details, and their health status. Microsoft Excel was used for recording and analyzing the collected data. Results: Out of 1016 respondents, 52% were male and 47.6% were female. Most of the respondents perfectly accept the vaccine, 35.5% are neutral and 5.9% are unacceptable toward vaccination. Post the vaccination of both doses, the occurrence of fever and chills is more common in the case of the first dose, whereas rashes are more common in the second dose, muscle pain and joint pain are common in both doses. Conclusion: This community-based project on acceptance and post-vaccination symptoms of vaccination among Indians reveals that the majority of participants showed a positive acceptance rate toward the vaccination but most of them are worried about the risk of side effects. In regard to post-vaccination symptoms, mild fever and chills are the most common side effect in the case of the first dose of vaccination, whereas muscle/joint pain was seen commonly in both the first and second doses of vaccination.

Symptoms and Side Effects of the ChAdOx1 nCoV-19 vaccine (AZD1222) among healthcare workers

Aim: Severe acute respiratory syndrome coronavirus (SARS-CoV-2) is a novel coronavirus which has infected millions of people across the globe in the form of a deadly pandemic. Safe and efficacious vaccines are needed urgently to prevent disease in the healthy population or at least decrease the intensity of illness post vaccination. Aim: To assess the post vaccination side effects among groups of individuals so that an effective vaccine can be proposed according to the individuals and thus avoiding reactogenicity, both systemic and local. Methods: A prospective study was conducted with the help of a web-based questionnaire (among health care workers) which used snowball sampling strategy and assigned persons aged ≥25-65 years, who received an intramuscular injection of the vaccine manufactured by Oxford-AstraZeneca. Safety and side effects were observed over a period of 15-20 days post vaccination to obtain results. Results: A total of 564 participants took part in the survey who received the vaccine via intramuscular route. Both systemic and local reactogenicity were recorded. Of the respondents, 280 (49.6%) people reported fever, 322 (57.18%) had pain, 89 (15.77%) had swelling and 53 (9.3%) had redness at the injection site. Total of 368 (65.2%) individuals suffered from body aches of whom 324 (57.4%) also reported headaches. Conclusion: Assessing the post vaccination symptoms, side effects and complications of AstraZeneca among different individuals helped in providing crucial and important information regarding the efficacy, safety and nature of the vaccine. Keywords: Covid-19, pandemic, vaccines, reactogenicity

Disentangling post-vaccination symptoms from early COVID-19.

BackgroundIdentifying and testing individuals likely to have SARS-CoV-2 is critical for infection control, including post-vaccination. Vaccination is a major public health strategy to reduce SARS-CoV-2 infection globally. Some individuals experience systemic symptoms post-vaccination, which overlap with COVID-19 symptoms. This study compared early post-vaccination symptoms in individuals who subsequently tested positive or negative for SARS-CoV-2, using data from the COVID Symptom Study (CSS) app.MethodsWe conducted a prospective observational study in 1,072,313 UK CSS participants who were asymptomatic when vaccinated with Pfizer-BioNTech mRNA vaccine (BNT162b2) or Oxford-AstraZeneca adenovirus-vectored vaccine (ChAdOx1 nCoV-19) between 8 December 2020 and 17 May 2021, who subsequently reported symptoms within seven days (N=362,770) (other than local symptoms at injection site) and were tested for SARS-CoV-2 (N=14,842), aiming to differentiate vaccination side-effects per se from superimposed SARS-CoV-2 infection. The post-vaccination symptoms and SARS-CoV-2 test results were contemporaneously logged by participants. Demographic and clinical information (including comorbidities) were recorded. Symptom profiles in individuals testing positive were compared with a 1:1 matched population testing negative, including using machine learning and multiple models considering UK testing criteria.FindingsDifferentiating post-vaccination side-effects alone from early COVID-19 was challenging, with a sensitivity in identification of individuals testing positive of 0.6 at best. Most of these individuals did not have fever, persistent cough, or anosmia/dysosmia, requisite symptoms for accessing UK testing; and many only had systemic symptoms commonly seen post-vaccination in individuals negative for SARS-CoV-2 (headache, myalgia, and fatigue).InterpretationPost-vaccination symptoms per se cannot be differentiated from COVID-19 with clinical robustness, either using symptom profiles or machine-derived models. Individuals presenting with systemic symptoms post-vaccination should be tested for SARS-CoV-2 or quarantining, to prevent community spread.FundingUK Government Department of Health and Social Care, Wellcome Trust, UK Engineering and Physical Sciences Research Council, UK National Institute for Health Research, UK Medical Research Council and British Heart Foundation, Chronic Disease Research Foundation, Zoe Limited.

Adverse Effects and Antibody Titers in Response to the BNT162b2 mRNA COVID-19 Vaccine in a Prospective Study of Healthcare Workers.

BackgroundThe relationship between postvaccination symptoms and strength of antibody responses is unclear. The goal of this study was to determine whether adverse effects caused by vaccination with the Pfizer/BioNTech BNT162b2 vaccine are associated with the magnitude of vaccine-induced antibody levels.MethodsWe conducted a single-center, observational cohort study consisting of generally healthy adult participants that were not severely immunocompromised, had no history of coronavirus disease 2019, and were seronegative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein before vaccination. Severity of vaccine-associated symptoms was obtained through participant-completed questionnaires. Testing for immunoglobulin G antibodies against SARS-CoV-2 spike protein and receptor-binding domain was conducted using microsphere-based multiplex immunoassays performed on serum samples collected at monthly visits. Neutralizing antibody titers were determined by microneutralization assays.ResultsTwo hundred six participants were evaluated (69.4% female, median age 41.5 years old). We found no correlation between vaccine-associated symptom severity scores and vaccine-induced antibody titers 1 month after vaccination. We also observed that (1) postvaccination symptoms were inversely correlated with age and weight and more common in women, (2) systemic symptoms were more frequent after the second vaccination, (3) high symptom scores after first vaccination were predictive of high symptom scores after second vaccination, and (4) older age was associated with lower titers.ConclusionsLack of postvaccination symptoms after receipt of the BNT162b2 vaccine does not equate to lack of vaccine-induced antibodies 1 month after vaccination.

Early solicited adverse events following the BNT162b2 mRNA vaccination, a population survey from Saudi Arabia

Post rollout safety for the coronavirus disease vaccines is crucial and recommended. To explore the early solicited adverse events (AE) following BNT162b2 mRNA vaccination in Saudi Arabia, we distributed an online survey to adults vaccinated with BNT162b2 over the first week of June 2021, to collect data on first (V1), second doses (V2), symptoms, severity, and outcome after an informed consent was obtained. We recruited 3639 BNT162b2 vaccinated individuals, of which one-third had received two doses, 63.3% were female, 77% were healthy, and 89% had 18–55 years of age, while only 9.8% had a history of allergy. Overall, 50.3% had any AEs after any dose, especially those younger than 55 years of age, female, history of comorbidity, and when adjusted for age and gender, lung or cardiovascular diseases. Overall, the most common AE were pain at the injection site (44%), tiredness (39%), or body ache (31%). Compared to V1, a higher rate of post-V2 systemic AE (36% vs. 51%). Most AEs started very early (within 3 days), and rarely delayed in recovery (>2 weeks). Anti-pyretic was the most commonly used (51.7%), a third of which was unnecessary. Only 1.7% required hospital admission. By multivariate analysis, predictors for admission were the presence of lung or immunocompromising diseases. In conclusion, common AEs after BNT162b2 in the real world were generally mild, self-limiting, higher after the second dose, and largely mimicking that reported in clinical trials. The causality of these AE and the persistence of post-vaccination symptoms needs to be investigated further.

S950 Symptomology Following SARS-CoV-2 mRNA Vaccination Among Patients With Inflammatory Bowel Disease Relative to Healthcare Workers

Introduction: A common reason for SARS-CoV-2 vaccine hesitancy among patients with inflammatory bowel disease (IBD) is fear of post-vaccination adverse events (PMID 33549869). Post-vaccination symptoms within an IBD cohort were less frequent among those on biologic and immunosuppressive therapies (PMID 34047304). However, post-vaccination symptomology in IBD relative to a non-IBD population is unknown. Methods: We compared post-vaccination symptoms between healthcare workers (HCW) without IBD at an academic medical center and adult IBD patients both at the same center and across the United States. Recipients of BNT162b2 (Pfizer) or mRNA-1273 (Moderna) vaccines received automated electronic surveys one week after each dose to assess frequency, severity and duration of local and systemic post-vaccine symptoms. Significant symptoms were defined as moderate severity (at least some interference with daily activities) or greater, or duration lasting >2 days. We compared proportions using Chi-square; multivariable logistic regression was used to adjust for confounding variables. Results: Overall, 2324 subjects including 1391 with IBD (65% Crohn’s disease, 35% ulcerative colitis) and 933 HCW were included (Table 1). Overall, symptom frequency was lower in IBD compared to HCW after each dose (D1: 37% vs. 54%, P < 0.0001; D2: 55.5% vs 73.2%, P < 0.0001). After each dose, IBD subjects reported fewer injection site symptoms, fever or chills, fatigue or malaise, headache, dizziness, or lightheadedness, and muscle, bone, joint or nerve symptoms compared to HCW (P < 0.001 for each), but experienced more gastrointestinal (GI) symptoms after D1 (2.9% vs 6.0%, P = 0.001) but not after D2 (12.1% vs 12.7%, P = 0.75). Most symptoms were non-severe and lasted < 2 days. There were no differences in the proportion of those experiencing significant AE after either dose between IBD and HCW (Figure 1). On multivariable analysis, age >50 years and IBD were independently associated with fewer symptoms after both D1 (age OR 0.60 (95% CI 0.50 – 0.73), P < 0.001; IBD OR 0.45 (0.37 – 0.55, P < 0.001) and D2 (age OR 0.52 (95% CI 0.42 – 0.63), P < 0.001; IBD OR 0.44 (0.35 – 0.55, P < 0.001). Conclusion: IBD patients had overall fewer local and systemic symptoms after each dose, except for more frequent GI symptoms after D1 only. People with IBD can be reassured that post-vaccination symptoms are significantly reduced compared to HCW. Further study of post-vaccination GI symptoms in IBD is warranted.Figure 1.: Proportion of subjects experiencing varying degrees of local and systemic symptom severity after each SARS-CoV-2 mRNA vaccine dose (IBD, purple dots; healthcare workers, black dots)Table 1.: Proportion of symptoms experienced in IBD patients compared to healthcare workers after each dose of mRNA vaccination

THE SAFETY OF VEROCELL COVID -19 (SINOPHARM) VACCINATION AMONG HEALTH CARE WORKERS IN KHYBER TEACHING HOSPITAL, PESHAWAR

Objectives: To determine the safety of Sinopharm Covid -19 vaccine among health care workers of Khyber Teaching Hospital (KTH, Peshawar).&#x0D; Material and Methods: This observational study was carried out to assess the side effects associated with the first dose of Sinopharm vaccine among health care workers in KTH Peshawar, Pakistan. Data was collected using a close ended questionnaire which was filled by the health care workers above 18 years of age. The participants were asked to monitor any side effects upto 1 week after the first dose of sinopharm vaccine administered to them. Data was analyzed using SPSS version 23 for macbook.&#x0D; Results: A total of 400 health workers were included in the study but only 155 partcipants responded by completing the questionnaire. It was observed that 63.9% of the participants who were vaccinated experienced at least one symptom after vaccination. The most common symptom was pain at injection site (36.8%) experienced during 15 – 30 minutes after vaccination. The occurrence of symptoms after vaccination was greater in age group 24-42 years which was 60.6% while in age group 43-60 years it was 39.4%. Our analysis shows that there is no association between co-morbidities and post vaccination symptoms (p&gt;0.01).&#x0D; Conclusion: Our study concludes that sinopharm vaccine has no severe/ moderate side effects and therefore safe for public use.&#x0D; Key words: Safety, SARS Covid-19, Sinopharm vaccine