Spontaneously reported adverse events following COVID-19 basic and booster immunizations in the Netherlands.

INTRODUCTION: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown. METHODS: The primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences. RESULTS: Lareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed. CONCLUSION: Spontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.

Adverse Events Following Oxford-Astrazeneca's COVID-19 Vaccine among Health Care Workers in a Tertiary Care Teaching Hospital: A Prospective Observational Study

Background: The ubiquitous elixir for mortality and morbidity inflicted by severe acute respiratory syndrome virus (SARS-CoV-2) has been a vaccine. These vaccines were approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there was a need for active surveillance of vaccinees to monitor for safety. Objective(s): This study reports adverse events following immunization with Oxford-AstraZeneca's COVID-19 vaccine (COVISHIELD). Material(s) and Method(s): The present study is an observational follow- up study to assess any adverse event occurrence following immunization (AEFI) within 7 days of vaccination among all eligible participants who were vaccinated. A structured safety surveillance questionnaire was administered consecutively to 714 participants. Vaccinees were observed for thirty minutes and followed telephonically for adverse events. Result(s): The overall incidence of any AEFI within 7 days was found to be 136/1000 vaccinations for the first dose. Out of total, 97 recipients reported with adverse events, 76.3% had AEFI within 24 h with fever as the most common symptom reported. The incidence of AEFI's was found to be associated with gender (P<0.02), age group (P<0.05) and occupation (P<0.05). No cases of hospitalization, disability or death were reported. Conclusion(s): Most of the adverse events were short-lived and observed in the first 24 h of vaccination. Incidence decreased in subsequent days and as no significant life-threatening adverse event was observed, this study might help reduce hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious disease.

A prospective and observational study to evaluate short-term adverse event following immunization of COVID-19 vaccination

Background: COVID-19 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was declared Pandemic by the World Health Organization on January 30, 2020. Vaccination represents the best possibility to resolve this pandemic. The current global challenge is the immunization against the SARS-CoV-2. However, the adverse events following immunization (AEFI) of the corona vaccine remains unclear. Aim and Objectives: This observational study aims to represent an accountable data of the AEFI between Covaxin and Covishield in North Indian population. Materials and Methods: The hospital-based prospective and observational study was employed from January 2021 to December 2021 for detecting and monitoring of AEFI in adults. All population vaccinated either covishield or covaxin with both doses were enrolled in the study as targeted population. Post-vaccination vaccinated population were telephonic follow-up with prior consent. Results: A total of 1015 vaccinated individuals were included in this study for assessment of AEFI. After statistical analysis of AEFI between both vaccination at 24 h P = 0.13, 3–7 days 0.4 and complete AEFI P = 0.06 observed. There is no association that was found significant P < 0.05 with the incidence of AEFI. Conclusion: The short-term outcome has not attribute any serious AEFI. This study demonstrated that both vaccines were well-tolerated and safe in generalized population. [ FROM AUTHOR] Copyright of Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research) is the property of Journal of Cardiovascular Disease Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Knowledge, Perception, and Reporting Practices of Healthcare Providers about Adverse Events Following the COVID-19 Vaccination in Iraq

Routine vaccination activities, such as detection, reporting, and management of adverse events following immunization (AEFIs), are generally handled by healthcare providers (HCPs). Safe vaccines against severe acute respiratory syndrome coronavirus (SARS-CoV-2) were introduced to control the Coronavirus Disease-19 (COVID-19) pandemic. The study aimed to assess the knowledge, perceptions, and practice of HCPs in Iraq about reporting adverse events following COVID-19 vaccination, and their association with sociodemographic variables. The study was a cross-sectional study that was carried out between August and September 2021 at the COVID-19 vaccination centers in Iraq. This study used an online and paper-based questionnaire, which was distributed among HCPs (physicians and pharmacists) in COVID-19 vaccination centers. A total of 117 pharmacists and physicians responded to the survey. Two-thirds of respondents were pharmacists. The majority of the respondents (49.6%) had fair knowledge levels on AEFIs. The perception of 43% of the participants was very good, whereas the perception of 28%, 23%, and 6% of the participants was fair, good, and poor, respectively. The reporting practice of HCPs was inadequate in 53% of respondents. The number of pharmacists who had good knowledge of AEFIs was significantly higher than that of the physicians. The age group (30-39) years of HCPs was significantly associated with more positive perception towards AEFIs. The number of pharmacists that had good perception was significantly higher than that of the physicians. Furthermore, HCPs aged 30 to 39 years had significantly higher reporting practices than other age groups. The study highlighted that the HCPs working at the COVID-19 vaccination centers have low knowledge of AEFIs. On the other hand, HCPs had more positive perception towards reporting AEFIs. Education programs and reference materials are needed to increase their awareness about AEFIs.Copyright © 2022 University of Baghdad - College of Pharmacy. All rights reserved.

Assessment of Adverse events following Immunization of COVID - 19 vaccination in Health Care Workers (HCWs) of Shaheed Hasan Khan Mewati Govt. Medical College Nalhar, Nuh, Haryana, India

Background: We assess the profile of adverse events following immunization of COVID - 19 vaccination of COVISHIELD in health care workers (HCWs) in Shaheed Hasan Khan Mewati Govt. Medical college Nalhar, Nuh, Haryana, India. Method(s): The Cross sectional and prospective observational study was conducted with a period of 3 months or till the desired sample size recruited in the study with follow up period of 15 days for all those subjects who were vaccinated for covid-19 in SHKM, GMC Hospital to look for AEFI with sample size more than 300. Active surveillance was done on days 3, 6 and 9 after days of vaccination for AEFI). Any AEFI noted will be managed as per the standard guidelines. Result(s): We present the results of an interim analysis of 400 patients out of total 550 participants with 244(61.00%) male and 156 (39.00%) female participants respectively. AEFIs following first dose were reported in 400 participants and 269 participants after second dose. Fever was the major AEFI with 150(37.50%) after first dose and 78(28.99%) after second dose respectively. In the study age wise AEFIs percentage of participants were also calculated. In the present study different systemic diseases percentage also calculated. Conclusion(s): The AEFIs associated with the COVISHIELD (ChAdOx1 nCoV-19), the COVID-19 vaccine injected in hospital health care workers is found to be safe for use in except for a few minor reactions.Copyright © RJPT. All right reserved.

Concurrent hypereosinophilic syndrome and deep vein thrombosis after Pfizer-BioNTech COVID-19 vaccination: A case report.

Herein, we report a case of eosinophilia syndrome and deep vein thrombosis presenting concurrently after the administration of the BNT162b2 mRNA-based coronavirus disease 2019 (COVID-19) vaccine. It is extremely rare to have both hypereosinophilic syndrome and deep vein thrombosis simultaneously. Both are serious diseases and should be treated with caution.

Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India.

BACKGROUND: Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. METHODS: Secondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. RESULTS: The majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. CONCLUSION: Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India.

A Retrospective Evaluation of Self-Reported Adverse Events Following Immunization with Different COVID-19 Vaccines in Türkiye.

BACKGROUND: The Sinovac and BioNTech vaccines were the first to be introduced in Türkiye to fight the ongoing global COVID-19 pandemic. As these vaccines had shown some side-effects in its clinical trial, we aimed to conduct a survey study to assess the short-term adverse events following immunization (AEFIs) in Türkiye. METHOD: A cross-sectional study was conducted using social and electronic media platforms by delivering a pre-formed and validated online questionnaire among people who had received at least one dose of the COVID-19 vaccine. This survey study focused on mass populations from different regions in Türkiye. A total of 603 responses were collected. Among these, 602 were selected based on complete answers and used for the assessment. The collected data were then analyzed to evaluate the various parameters related to the AEFIs of the respondents. RESULTS: Among the total 602 participants, 20.8% were male, and 78.7% were female, actively answering all of the constructive questions. Most of the respondents were between 18-30 years of age. We found that a total of 23.3% of the total respondents had been infected with the SARS-CoV-2 virus. Our survey revealed that out of 602 volunteers, the rate of experiencing physical discomfort was higher in participants who had received the Pfizer-BioNTech vaccine at all three doses than in those who had received the Sinovac vaccine. When all vaccine types were examined, the most common side effect was pain at the injection site, reported by 75.19% participants. When the side effects were compared according to vaccine types, there was a significant difference only in terms of fever. Fever rates in those who had received the Pfizer-BioNTech vaccine (20.96%) were found to be significantly higher than those who had received the Sinovac vaccine (8%). CONCLUSIONS: The studied vaccines showed minor side effects and there was no significant difference between the vaccines in terms of other side effects. Moreover, further research is needed to determine the efficacy of the existing vaccines in preventing SARS-CoV-2 infections or after-infection hospitalization.

Safety and adverse events following COVID-19 vaccination among people with epilepsy: A cross-sectional study.

OBJECTIVE: Epilepsy is a non-communicable disease costing a massive burden globally. It is known that there is increased prevalence of morbidity and mortality following COVID-19 infection among people with epilepsy (PWE). However, there is limited information about the adverse events following COVID-19 immunization among PWE. Hence, this study aimed to assess the safety and adverse events following immunization (AEFI) of various COVID-19 vaccines among PWE from our centre, focusing on neurological AEFI. METHODS: This cross-sectional study recruited 120 adult PWE from the Neurology Clinic of the Universiti Kebangsaan Malaysia Medical Centre (UKMMC). Consent-taking was conducted via synchronous or asynchronous approaches, followed by a phone call interview session. The interview collected socio-demographic information, epilepsy-related variables, and vaccination-related variables. Univariate analysis and multiple logistic regression analysis were done to confirm factors associated with the AEFI of COVID-19 vaccination. RESULTS: Among all types of COVID-19 vaccines, most of the PWE received the Cominarty® COVID-19 vaccination (52.5%). Overall, local AEFI was the quickest to develop, with an average onset within a day. PWE with normal body mass index (BMI) had a higher risk of developing both local and systemic AEFI compared to those underweight and obese PWE (OR: 15.09, 95% CI 1.70-134.28, P = 0.02). SIGNIFICANCE: COVID-19 vaccines are safe for PWE. AEFI among PWE are similar to those of the general population following COVID-19 vaccination. Therefore, clinicians should encourage PWE to take COVID-19 vaccines.

Adverse Events Following Immunization with mRNA and Viral Vector Vaccines in Individuals with Previous SARS-CoV-2 Infection from the Canadian National Vaccine Safety Network.

BACKGROUND: Adults previously infected with SARS-CoV-2 develop short-term immunity and may have increased reactogenicity to COVID-19 vaccines. This prospective, multi-center active surveillance cohort study examined the short-term safety of COVID-19 vaccines in adults with a prior history of SARS-CoV-2. METHODS: Canadian adults vaccinated between December 22, 2020 and November 27, 2021 were sent an electronic questionnaire 7 days post dose 1, dose 2 and dose 3 vaccination. The main outcome was health events occurring in the first 7 days after each vaccination that prevented daily activities, resulted in work absenteeism or required a medical consultation, including hospitalization. RESULTS: Among 684,998 vaccinated individuals, 2.6% (18,127/684,998) reported a prior history of SARS-CoV-2 infection a median of 4 months (interquartile range 2-6 months) previously. After dose 1, individuals with moderate (bedridden) to severe (hospitalized) COVID-19 who received BNT162b2, mRNA1273 or ChAdox1-S vaccines had higher odds of a health event preventing daily activities, resulting in work absenteeism or requiring medical consultation; adjusted odds ratio (AOR) 3.96 (95% CI 3.67-4.28) for BNT162b2, 5.01 (4.57-5.50) for mRNA1273 and 1.84 (1.54-2.20) for ChAdox1-S compared to no infection. Following dose 2 and 3, the greater risk associated with previous infection was also present but attenuated compared to dose 1. For all doses, the association was lower or absent after mild or asymptomatic infection. CONCLUSION: Adults with moderate or severe previous SARS-CoV-2 infection were more likely to have a health event sufficient to impact routine activities or require medical assessment in the week following each vaccine doses.

Local and Systemic Adverse Reactions Following Covid-19 Vaccine

The mass vaccination against novel coronavirus infection (COVID-19) requires to dynamically evaluate risks of adverse events following immunization to prevent them and develop vaccination tactics for various population groups. We describe a clinical case of reaction following administration of the second dose of the heterologous recombinant adenovirus based COVID-19 vaccine Gam-COVID-Vac (Sputnik V) in 48-year-old female healthcare worker. No adverse events after administration of the first dose were recorded. After vaccination, the patient complained of weakness, malaise, headache, loss of appetite, and nausea that lasted for a single day. Reaction at the injection site appeared 10 hours after vaccination manifested as pruritic erythema, induration area up to 1.5 cm size, sharp pain, which resolved within 24 hours. On the second day post-vaccination, an inflammation area up to 1.5 cm size within the Bacillus Calmette-Guerin (BCG) scar site was noted and manifested as erythema, induration, painful to palpate, pruritus located 2 cm away from the injection site. BCG scar reaction with dull pain and severe pruritus lasted for three weeks. Erythema and induration at the BCG scar site resolved two months after the onset, which were resolved by using antihistaminic agent. The patient was vaccinated according to the Russian Federation Immunization Program, not associated with any adverse events following immunization. The patient had comorbidities such as vasomotor rhinitis, urolithiasis, stomach, duodenal ulcer, type 2 diabetes, arterial hypertension, and her body mass index of 35.2. The patient permanently receives antihypertensive and antihyperglycemic drugs, and has allergic reaction in the form of urticaria to Berodual. The patient has menopause during two years, but a five-day postmenopausal bleeding three days after vaccination with the second dose was noted. Thus, a high-quality surveillance of any local and systemic reactions associated with vaccination is needed to reveal adverse events to the vaccines against COVID-19 and elaborate a safe immunization program for preventing COVID-19.

A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5-17 Years) Living in Saudi Arabia.

The objective of this study is to assess the frequency and severity of adverse events following immunization (AEFI) in Indian children aged 5-17 years who received the Pfizer-BioNTech mRNA COVID-19 vaccine, as well as to investigate for predictors of AEFI. To examine AEFI following the first and second doses of Pfizer's vaccine, semi-structured questionnaires were distributed as Google forms at Indian schools in Saudi Arabia. The 385 responses included 48.1% male and 51.9% female children, with 136 responses of children aged 5-11 years (group A) and 249 responses from children aged 12-17 years (group B). Overall, 84.4% of children had two shots. The frequency of AEFI was reported to be higher after the first dose than after the second (OR = 2.12, 95% CI = 1.57-2.86). The reported AEFIs included myalgia, rhinitis, local reaction with fever, a temperature of 102 °F or higher, and mild to moderate injection site reactions. While group B frequently reported multiple AEFIs, group A typically reported just one. Local reaction with low grade fever was more frequently reported in group B after the first dose (24.1%) and second dose (15.4%), while local reaction without low grade fever was most frequently observed in group A after the first (36.8%) and second dose (30%). Only prior COVID-19 infection (OR = 2.98, 95% CI = 1.44-6.2) was associated with AEFI after the second dose in the study sample, whereas male gender (OR = 1.71, 95% CI = 1.13-2.6) and prior COVID-19 infection (OR = 2.95, 95% CI = 1.38-6.3) were predictors of AEFI after the first dose. Non-serious myocarditis was reported by only one child. According to the analysis conducted, the Pfizer's mRNA COVID-19 vaccination was found to be safe in Indian children.

Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines.

In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.

Monitoring System for Adverse Events Following Immunization in Russia and the World. Modern aspects and problems

Relevance. During a pandemic, the epidemiological well-being of the population of the whole world depends on the vaccination of each individual person, as cells of the immune layer. Only reliable and open information about adverse events after the use of vaccines, obtained in a timely manner in the process of continuous monitoring, can support the confidence and adherence of the population to vaccination. Aim. To assess the monitoring system for AEFI (Adverse Events Following Immunization) in the Russian Federation and other countries. Materials and methods. A descriptive epidemiological study was conducted with a review of regulatory and methodological documents, forms of federal statistical observation, information from the AIS «DRAID» (Analytical Information System «Department of registration and accounting of infectious diseases» program in Moscow, acts of investigation of post-vaccination complications, which were carried out by specialists from the branches of the Center for Hygiene and Epidemiology in Moscow, sources: eLIBRARU.ru, cyberleninka.ru, information from WHO’s websites, Internet resources for monitoring AEFIs in different countries and websites of manufacturers of COVID-19 vaccines, instructions for vaccines. Conclusion. Thus, it is almost impossible for an epidemiologist working in one of the departments that participates in the monitoring of AEFIs to conduct a full-fledged prospective and retrospective epidemiological analysis and draw unambiguous conclusions about the AEFIs based only on data from open sources and forms of state statistical observation. There is a need for interaction and exchange of information between the subjects of monitoring. © 2022, Numikom. All rights reserved.

Investigation of Adverse Events Experienced by Healthcare Workers following Immunization with Homologous orHeterologous COVID-19 Booster Vaccinations.

OBJECTIVE: A comparative analysis was performed to investigate the potential risk factors of Adverse Events Following Immunization (AEFI) after receiving different booster vaccines. METHODS: From 18 January 2021 to 21 January 2022, the Health Care Workers (HCWs) of Guizhou Provincial Staff Hospital (Guizhou Province, China) who received a third Booster vaccine, that was either homologous (i.e., (i) a total of three doses of Vero cell vaccine or (ii) three doses of CHO cell vaccine) or (iii) heterologous with two first doses of Vero cell vaccine, being either CHO cell vaccine or adenovirus type-5 (Ad5) vectored COVID-19 vaccine, were asked to complete a self-report questionnaire form to provide information on any AEFI that may have occurred in the first 3 days after vaccination with the booster. The frequency of AEFI corresponding to the three different booster vaccines was compared, and the risk factors for predicting AEFI were determined by multivariate logistic regression analysis. RESULTS: Of the 904 HCWs who completed the survey, 792 met the inclusion criteria. The rates of AEFI were 9.8% (62/635) in the homologous Vero cell booster group, 17.3% (13/75) in the homologous CHO cell booster group, and 20.7% (17/82) in the heterologous mixed vaccines booster group, and the rates were significantly different (c2 = 11.5, p = 0.004) between the three groups of vaccines. Multivariate logistic regression analysis showed that: (1) compared to the homologous Vero cell booster group, the risk of AEFI was about 2.1 times higher (OR = 2.095, 95% CI: 1.056-4.157, p = 0.034) in the CHO cell booster group and 2.5 times higher (OR = 2.476, 95% CI: 1.352-4.533, p = 0.003) in the mixed vaccines group; (2) the odds for women experiencing AEFI were about 2.8 times higher (OR = 2.792, 95% CI: 1.407-5.543, p = 0.003) than men; and (3) compared to the non-frontline HCWs, the risk of AEFI was about 2.6 times higher (OR = 2.648, 95% CI: 1.473-4.760, p = 0.001) in the doctors. CONCLUSION: The AEFI in all three booster groups are acceptable, and serious adverse events are rare. The risk of AEFI was higher in doctors, which may be related to the high stress during the COVID-19 epidemic. Support from government and non-governmental agencies is important for ensuring the physical and mental health of HCWs.

Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS.

Background and purpose: Serious adverse events following immunization (AEFI) associated with the COVID-19 vaccines, including BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen), and mRNA-1273 (Moderna), have not yet been fully investigated. This study was designed to evaluate the serious AEFI associated with these three vaccines. Methods: A disproportionality study was performed to analyze data acquired from the Vaccine Adverse Event-Reporting System (VAERS) between 1 January 2010 and 30 April 2021. The reporting odds ratio (ROR) method was used to identify the association between the COVID-19 vaccines BNT162b2, Ad26.COV2.S, and mRNA-1273 and each adverse event reported. Moreover, the ratio of the ROR value to the 95% CI span was applied to improve the credibility of the ROR. The median values of time from vaccination to onset (TTO) for the three vaccines were analyzed. Results: Compared with BNT162b2 and mRNA-1273, Ad26.COV2.S vaccination was associated with a lower death frequency (p < 0.05). Ad26.COV2.S vaccination was associated with a lower birth defect and emergency room visit frequency than BNT162b2 (p < 0.05). There were 6,605, 830, and 2,292 vaccine recipients who suffered from COVID-19-related symptoms after vaccination with BNT162b2, Ad26.COV2.S, and mRNA-1273, respectively, including people who were infected by COVID-19, demonstrated a positive SARS-CoV-2 test, and were asymptomatic. Serious AEFI, including thromboembolism, hemorrhage, thrombocytopenia, cardiac arrhythmia, hypertension, and hepatotoxicity, were associated with all three vaccines. Cardiac failure and acute renal impairment events were associated with BNT162b2 and mRNA-1273, while seizure events were associated with BNT162b2 and Ad26.COV2.S. The median values of TTO associated with the three vaccinations were similar. Conclusion: These findings may be useful for health workers and the general public prior to inoculation, especially for patients with underlying diseases; however, the risk/benefit profile of these vaccines remains unchanged. The exact mechanism of SARS-CoV-2 vaccine-induced AEFI remains unknown, and further studies are required to explore these phenomena.

COVID-19 vaccination uptake and adverse events following COVID-19 immunization in pregnant women in Northern India: a prospective, comparative, cohort study.

Objectives: The most commonly used vaccine in India, Covishield, is a recombinant adenovirus vector vaccine for which safety data in pregnant women are not available. The present study was conducted to assess the uptake of COVID-19 vaccines and monitor adverse events following COVID-19 immunization among pregnant women in northern India. Patients and Methods: A prospective cohort study was conducted among pregnant women registered with the antenatal clinics in Chandigarh Union Territory (U.T.) in northern India. The study included 247 pregnant women and a comparative group of age-matched, non-pregnant women (247) who received the first dose of the COVID-19 vaccine and were followed up by telephone interviews for adverse events following immunization at three time points until 28 days after vaccination. Multivariate regression (logistic and linear) was used for the adjusted analysis, with adverse events following immunization and the duration of adverse events following immunization as the outcomes. Results: The COVID-19 vaccination uptake rate was 66.8% among the pregnant women. The 28-day incidence rate of adverse events following immunization among the pregnant women was 76.5%. The overall 28-day incidence of adverse events following immunization in pregnant women did not differ significantly from that of non-pregnant women (P=0.153). Conclusion: The Covishield vaccine is safe for pregnant women in India. Further follow-up of the cohort for feto-maternal outcomes needs to be conducted with an adequate sample size to confirm the overall safety profile of the vaccine.

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

Introduction: Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited. Aim: We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy. Methods: We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines. Results: During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69-0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05-1.38 and ROR 1.26, 95% CI 1.08-1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64-0.84). In addition, 5.8% of ICSRs reported a fatal outcome. Conclusions: No strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.

Analysis of Adverse Effects of COVID-19 Vaccines Experienced by Healthcare Workers at Guizhou Provincial Staff Hospital, China.

OBJECTIVE: A retrospective survey was conducted of adverse events following immunization (AEFI) experienced by health care workers (HCWs) in a relatively remote ethnic region in southwest China (Guizhou Province) who received COVID-19 vaccines. METHODS: From 18 January 2021 to 21 January 2022, all HCWs of Guizhou Provincial Staff Hospital, China, who received at least one dose of inactivated COVID-19 vaccine (Vero cell), recombinant novel coronavirus vaccine (CHO cell), or one dose of adenovirus type-5 (Ad5) vectored COVID-19 vaccine were asked to complete a self-report questionnaire to provide information on any adverse events that may have occurred in the first 3 days after injection. The frequency of AEFI corresponding to the three types of vaccines were compared and the potential risks of AEFI due to the three different vaccines were predicted by multivariate logistic regression analysis. RESULTS: Of the 904 HCWs who completed the survey, the rates of AEFI were 10.1% (80/794) due to Vero cell, 16.3% (13/80) due to CHO cell, and 46.67% (14/30) due to Ad5 vectored vaccines, and the rates were significantly different (χ2 = 38.7, p < 001) between the three vaccines. Multivariate logistic regression models predict that (1) compared to the Ad 5 vectored group, the risk of AEFI occurrence in the Vero cell group was reduced by about 85.9% (OR = 0.141, 95% CI: 0.065-0.306, p < 0.001) and in the CHO cell group by about 72.1% (OR = 0.279, 95% CI: 0.107-0.723, p = 0.009), (2) the odds for women experiencing AEFI were about 2.1 (OR = 2.093, 95% CI: 1.171-3.742, p = 0.013) times as high as those of men, and (3) the risk of AEFI for HCWs with a Bachelor's degree or above was about 2.2 (OR = 2.237, 95% CI: 1.434-3.489, p = 0.001) times higher than in HCWs who do not have a Bachelor's degree. CONCLUSIONS: 1. The inactivated COVID-19 vaccine (Vero cell), recombinant novel coronavirus vaccine (CHO cell), and adenovirus type-5 (Ad5) vectored COVID-19 vaccine made in China are safe and relatively broad-spectrum. 2. The prevalence of AEFI is more common in women healthcare workers. 3. The risk of AEFI was higher in those with a Bachelor's degree or above and may be related to the psychological and social effects triggered by the global COVID-19 pandemic.

Advancing the Science of Vaccine Safety During the Coronavirus Disease 2019 (COVID-19) Pandemic and Beyond: Launching an International Network of Special Immunization Services.

Within 2 years after the start of the coronavirus disease 2019 (COVID-19) pandemic, novel severe acute respiratory syndrome coronavirus 2 vaccines were developed, rigorously evaluated in large phase 3 trials, and administered to more than 5 billion individuals globally. However, adverse events of special interest (AESIs) have been described post-implementation, including myocarditis after receipt of messenger RNA (mRNA) vaccines and thrombosis with thrombocytopenia syndrome after receipt of adenoviral vector vaccines. AESIs are rare (<1 to 10/100 000 vaccinees) and less frequent than COVID-19 complications, though they have associated morbidity and mortality. The diversity of COVID-19 vaccine platforms (eg, mRNA, viral vector, protein) and rates of AESIs both between and within platforms (eg, higher rate of myocarditis after mRNA-1273 vs BNT162b2 vaccines) present an important opportunity to advance vaccine safety science. The International Network of Special Immunization Services has been formed with experts in vaccine safety, systems biology, and other relevant disciplines to study cases of AESIs and matched controls to uncover the pathogenesis of rare AESIs and inform vaccine development.