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Objective: To assess the safety of co-immunization of group A and group C meningococcal polysaccharide conjugate vaccine (MPCV-AC) and hepatitis B vaccine (HepB). Methods: The data on adverse event following immunization (AEFI) and vaccination with MPCV-AC and HepB among age-eligible children in Anhui Province, China from 2020 to 2022 were obtained through the National Immunization Information System and Anhui Provincial Immunization Information System. The reported incidence rates of AEFI were compared among children who received the two vaccines simultaneously and separately. Results: The reported incidence rates of AEFI were 48.03/105 (280 cases) following co-immunization of MPCV-AC (lsl dose) and HepB (3rd dose), 56.37/105 (314 cases) following MPCV-AC (1st dose), and 51.96/105 (283 cases) following HepB (3rd dose). The incidence rates of common reactions in the three groups were 43.91/105 (256 cases, 51.35/105 (286 cases), and 48.65/105 (265 cases), respectively; the incidence rates of adverse events in the three groups were 4.12/105 (24 cases, 4.85/105 (27 cases,and 3.30/105 (18 cases), respectively. There were no significant differences between the co-immunization group and the separate vaccination groups in the risk of AEFI, common reactions, and adverse events. Conclusion: Co-immunization of MPCV-AC and HepB does not increase the risk of AEFI, which can serve as a scientific basis for co-immunization of MPCV-AC and HepB in 6-month-old children. [ABSTRACT FROM AUTHOR]

Aim: This study aimed at assessing COVID-19 vaccine hesitancy, adverse events after immunization, and associated factors among the general population during the early phase of the COVID-19 vaccination program in Ethiopia. Subject and methods: We conducted a national online survey of 853 persons among the Ethiopian general population between June 19 and July 31, 2021, in three languages that included Amharic, Afan Oromo, and English. Responses obtained from Google Forms were downloaded in Excel format and then filtered, coded, exported, and analyzed using the Statistical Package for Social Sciences (SPSS) version 26. Binary logistic regression was employed to identify factors associated with the outcome variables, and p < 0.05 was used as the cutoff point to declare the significance association. This study was approved by the Ethical Review Committee of the School of Pharmacy, College of Health Sciences, Addis Ababa, Ethiopia (ERB/290/13/2021). Results: Of the 853 study participants, the majority were male (57.4%), and their mean (±SD) age was 32.0 (±13.57) years. More than half, namely 61.0% (95% CI: 57.1%–64.8%) were hesitant to take the COVID-19 vaccine. Fear of side effects (21.3%) and doubts about its effectiveness (16.9%) were their main reasons for not receiving the vaccine. Of the 214 participants who received the first dose of the COVID-19 vaccine, 34.6% were hesitant to get it. The overall mean score (±SD) of the attitude of the participants toward COVID-19 and its vaccine was 31.21 (±3.21) from an overall score of 45, with 53.6% scoring below the mean and having a poor attitude toward COVID-19. Among the 145 (67.8%) participants that experienced adverse events following immunization (AEFI) with the COVID-19 vaccine, the most common were pain at the injection site (52.4%), headache (40.7%), and fatigue (35.2%). The odds of vaccine hesitancy were reduced by 57% and 93% among participants with good attitudes toward the COVID-19 vaccine (AOR: 0.43; 95% CI: 0.29–0.65) and those who recommended the vaccine to other people (AOR: 0.07; 95% CI: 0.04–0.12), respectively. The odds of COVID-19 vaccine side effects were reduced by 57% and 69% among participants in the age group of 30–39 years (AOR: 0.43; 95% CI: 0.19–0.98) and 40–49 years (AOR: 0.31; 95% CI: 0.12–0.86), respectively, when compared to those in the age group of 18–29 years. Conclusion: Hesitancy to first and second doses of the COVID-19 vaccine was high among the general population in Ethiopia. Fear of adverse effects and doubts about its effectiveness were the most frequent reasons for not receiving the COVID-19 vaccine. More than half of the participants had a poor attitude toward COVID-19 and its vaccine. More than two thirds of vaccinated participants experienced one or more AEFIs with COVID-19 vaccine administration. [ABSTRACT FROM AUTHOR]

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021–May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies. [ABSTRACT FROM AUTHOR]

Despite a lack of clinical data demonstrating the effectiveness of alcohol swab cleansing prior to vaccinations as a prophylactic measure to prevent skin infections, it is recommended for vaccine administration by the Canadian Immunization Guide. The objective of this study was to evaluate the risk of adverse events after omitting alcohol skin cleansing in long-term care (LTC) residents receiving vaccinations during the COVID-19 pandemic. Two medium-sized LTC homes participated in a cohort study, whereby one LTC used alcohol swab cleansing prior to resident vaccinations and the other did not. All residents received two doses of the BNT162b2 COVID-19 vaccine separated by an average (SD) 29.3 (8.5) days. The electronic chart records of participants were reviewed by researchers blinded to group allocation to assess for the presence of adverse events following immunization (AEFI), including reactogenicity, cellulitis, abscess, or systemic reactions. Log-binomial regression was used to compute risk ratios (with 95% confidence intervals) of an AEFI according to alcohol swab status. 189 residents were included, with a total of 56 AEFI between the two doses. The risk of reactogenicity (adjusted RR 0.54, 95% CI 0.17–1.73) or systemic reactions (adjusted RR 0.75, 95% CI 0.26–2.13) did not differ for the residents that received alcohol skin antisepsis compared to those that did not. There were no cases of cellulitis or abscess. This study did not demonstrate an elevated risk of AEFI in LTC residents receiving two doses of the BNT162b2 mRNA COVID vaccine without alcohol skin antisepsis.

Introduction: Savannah Region witnessed a decline in measles-rubella (MR) vaccination coverage prior to the measles outbreak in 2022. This study aimed to assess contributory factors of the low routine MR vaccination coverage and proffer recommendations to improve vaccination uptake. Methods: A cross-sectional study was conducted in two districts (Bole and Central Gonja) of Savannah Region from December 2022 to June 2023. Caregivers of children 18–59 months were randomly selected and interviewed using a structured questionnaire. Bivariate and multivariate logistic regression were performed to assess predictors of MR vaccination status. Results: Children of caregivers with inadequate knowledge of MR vaccination (AOR = 0.58, 95 %CI: 0.47–0.72), travelled more than five km to access health services (AOR = 0.48, 95 %CI: 0.39–0.59), described health workers attitude as poor (AOR = 0.44, 95 %CI: 0.26–0.74), and those who sought treatment for adverse events following immunization (AEFI) from the pharmacy (AOR = 0.65, 95 %CI: 0.51–0.84) were less likely to complete MR vaccination. On the contrary, children of female sex (AOR = 1.27, 95 %CI: 1.05–1.53), aged 24–59 month (AOR = 2.56, 95 %CI: 1.05–1.53), caregivers with primary or secondary education (AOR = 1.43, 95 %CI: 1.11–1.84; and AOR = 2.23, 95 %CI: 1.64–3.03 respectively), and those who did not experience rescheduling of vaccination sessions (AOR = 1.61, 95 % CI: 1.25–2.01) were more likely to complete routine MR vaccination schedule. Conclusion: Inadequate caregiver knowledge, poor geographical access to health services, poor healthcare worker attitude, and non-institutional management of AEFI significantly contributed to the low MR vaccination uptake in the Savannah Region. Adopting tailored approaches to addressing these factors could improve vaccination coverage.

Introduction: The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15–18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine. Methodology: This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022). Results: A total of 72,771 adolescents (15–18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study. Conclusion: Thus, it can be concluded that Covaxin was found to be safe in adolescents (15–18 years).

To address the lack of an active vaccine safety surveillance system in Japan, the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study was initiated in 2021 as a pilot system using existing health insurance claims data and vaccination records. This study evaluated the value of the VENUS study by assessing the incidence of immune thrombocytopenic purpura (ITP) and Guillain-Barré syndrome (GBS) following vaccination with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) using a self-controlled case series (SCCS) design. Incidence rate ratios for ITP during 28-day and 42-day risk periods were 0.89 (95% confidence interval [CI], 0.12–6.4), and 0.58 (95% CI, 0.081–4.2), respectively. Neither was statistically significant. Incidence rate ratios could not be estimated for GBS due to the limited sample size. The VENUS study can provide valuable insights to facilitate the establishment of an advanced vaccine monitoring system in Japan. [ABSTRACT FROM AUTHOR]

Background: Seasonal influenza vaccines (SIV) authorized for use in Canada have all undergone rigorous regulatory assessments for safety and effectiveness. Serious adverse events following immunization (AEFI) can occur, though they are rare. Continuous safety surveillance of vaccines during the post-marketing phase is a critical component of vaccination programs. This enables the detection of rare, late onset, or unexpected adverse events. An updated safety summary following the introduction of any new vaccines and/or formulations to immunization programs is necessary for refining the risk-benefit profile of a specific vaccine and maintaining public confidence. Here we provide an updated safety summary for SIVs distributed during the 2021/2022 influenza season from AEFI reports submitted to the Canadian Adverse Event Following Immunization Surveillance System (CAEFISS) and the Canadian Vigilance Database (CVD). Methods: We searched CAEFISS and CVD for individuals who were vaccinated with a SIV between October 1, 2021, and March 31, 2022. Descriptive statistics were calculated, including median age of vaccinated individuals, vaccines co-administered with SIV, and the most frequently reported AEFIs. Crude AEFI reporting rates were calculated by severity of the AEFI report, and SIV-type using doses distributed data. Medical reviews were conducted for reports including death, serious events (or outcomes) after SIV were administered alone, and selected adverse events (i.e., anaphylaxis, Guillain-Barré syndrome, febrile seizures, oculo-respiratory syndrome). Disproportionality analysis was used to identify potential safety signals among SIV and AEFI pairs. Results: There were 448 AEFI reports, with most AEFI classified as non-serious events (84.2%). The majority of reports described vaccination in adults at least 65 years of age (38.6%). The most frequently reported AEFIs were vaccination site pain, urticaria, pyrexia and rash. Medical review of AEFI reports did not find any evidence that reported deaths were related to vaccination with SIV. Among serious reports, nervous system disorders were the most commonly reported medical conditions. A higher number of events related to vaccination errors were also identified using disproportionality analysis. Conclusion: Findings from our analysis of reports to CAEFISS and CVD following vaccination with SIV are consistent with the known safety profile of SIVs distributed during the 2021/2022 influenza season. The majority of reports were non-serious with the most common AEFI symptoms occurring at the vaccination site or systemic symptoms that were self-limiting. The majority of vaccination error reports involved the administration of the vaccine at an inappropriate site, although no serious AEFIs were reported. [ABSTRACT FROM AUTHOR]

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021–May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies.

The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research. [ABSTRACT FROM AUTHOR]

Objectives Age-specific information regarding myocarditis/pericarditis in adolescents following mRNA-based coronavirus disease 2019 (COVID-19) vaccination in Asia remains insufficient. This study investigated the incidence and clinical characteristics of myocarditis/pericarditis in Republic of Korea adolescents after mRNA-based COVID-19 vaccination. Methods This retrospective descriptive study utilized patient data from the Korea Immunization Management System. Incidence rates were calculated according to age and sex. Clinical characteristics (symptoms/signs, laboratory values, and imaging results) were compared between mild and severe cases. Results Between July 19, 2021 and September 30, 2022, 3,728,224 individuals aged 12 to 19 years received 6,484,165 mRNA-based COVID-19 vaccines, and 173 cases met the case definition for myocarditis/pericarditis: 151 mild (87.3%) and 22 severe (12.7%). The incidence was 3.8-fold higher in males than in females. Troponin I/troponin T was elevated in 96% of myocarditis cases, demonstrating higher sensitivity than creatine kinase-myocardial band (67.6%) or C-reactive protein (75.2%). ST-segment or Twave on electrography abnormalities were found in 60.3% (85/141). Paroxysmal/sustained atrial/ventricular arrhythmias were more common in severe than in mild cases (45.5% vs. 16.8%, p=0.008). Edema on T2-weighted magnetic imaging occurred in 21.6% (8/37) and 62.5% (5/8) of mild and severe cases, respectively (p=0.03). Abnormal pericardial fluid collection or pericardial inflammation was found in 75.4% of pericarditis cases (49/65). Conclusion Myocarditis/pericarditis occurred in rare cases following mRNA-based COVID-19 vaccination. Most cases were mild, but the incidence was higher in adolescent males and after the second dose. As bivalent severe acute respiratory syndrome coronavirus 2 mRNA vaccination started in South Korea in October 2022, the post-vaccination incidence of myocarditis/pericarditis should be closely monitored, considering clinical characteristics.

Abstract Background Since the deployment of Coronavirus Disease 2019 (COVID-19) vaccines, skepticism about the safety, incidence, and severity of Adverse Events Following Immunization (AEFI) was a concern. The study has two main objectives. First, to analyze AEFIs following COVID-19 vaccines (Pfizer-BioNTech, AstraZeneca, Sputnik, and Sinopharm) during the vaccination campaign in Lebanon and correlate them with age and gender. Second, to correlate Pfizer-BioNTech and AstraZeneca vaccines’ AEFI with the dose administered. Methods A retrospective study was carried out between February 14th, 2021, and February 14th, 2022. AEFI case reports received to the Lebanese Pharmacovigilance (PV) Program were cleaned, validated, and analyzed using SPSS software. Results A total of 6808 AEFI case reports were received to the Lebanese PV Program during the period of this study. Case reports were mostly received from females (60.7%) and from vaccine recipients aged 18–44 years. As for the vaccine type, AEFIs occurred more frequently with the AstraZeneca vaccine compared to the Pfizer-BioNTech vaccine. The latter had AEFIs mainly following dose 2, whereas AEFIs with the AstraZeneca vaccine were more frequently reported after dose 1, with general body pain being the most reported systemic AEFI with PZ (34.6%), while fatigue was the most reported AEFI with AZ vaccine (56.5%). Conclusions The AEFI reported with COVID-19 vaccines in Lebanon were aligned with those reported worldwide. The incidence of rare serious AEFIs should not discourage the public from getting vaccinated. Further studies are needed to evaluate their long-term potential risk.

Background: Between March, 2020 and December, 2021 due to cholera and coronavirus disease 2019 (COVID-19) pandemics, there were 1,534 cholera cases with 14 deaths and 136,065 COVID-19 cases with 3,285 deaths reported respectively in Uganda. This study investigated mass vaccination campaigns for the prevention of the two pandemics namely: oral cholera vaccine (OCV) and COVID-19 vaccine coverage; adverse events following immunization (AEFI); barriers and enablers for the vaccine uptake and assessed water, sanitation and hygiene (WASH) conditions in the six cholera and COVID-19 hotspot districts of Uganda. Methods: A household survey was conducted between January and February, 2022 in the six cholera hotspot districts of Uganda which had recently conducted OCV mass vaccination campaigns and had ongoing COVID-19 mass vaccination campaigns. The survey randomly enrolled 900 households with 4,315 persons of whom 2,085 were above 18 years. Data were collected using a data entry application designed in KoBoToolbox and analysed using STATA version 14. Frequencies, percentages, odds ratios, means, confidence intervals and maps were generated and interpreted. Results: The OCV coverage for dose one and two were 85% (95% CI: 84.2—86.4) and 67% (95% CI: 65.6—68.4) respectively. Among the 4,315 OCV recipients, 2% reported mild AEFI, 0.16% reported moderate AEFI and none reported severe AEFI. The COVID-19 vaccination coverage for dose one and two were 69.8% (95% CI: 67.8–71.8) and 18.8% (95% CI: 17.1–20.5) respectively. Approximately, 23% (478/2,085) of COVID-19 vaccine recipient reported AEFI; most 94% were mild, 0.6% were moderate and 2 cases were severe. The commonest reason for missing COVID-19 vaccine was fear of the side effects. For most districts (5/6), sanitation (latrine/toilet) coverage were low at 7.4%—37.4%. Conclusion: There is high OCV coverage but low COVID-19 vaccine and sanitation coverage with high number of moderate cases of AEFI recorded due to COVID-19 vaccines. The low COVID-19 vaccine coverage could indicate vaccine hesitancy for COVID-19 vaccines. Furthermore, incorporation of WASH conditions assessment in the OCV coverage surveys is recommended for similar settings to generate data for better planning. However, more studies are required on COVID-19 vaccine hesitancy. [ABSTRACT FROM AUTHOR]

Introduction: The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15-18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine. Methodology: This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022). Results: A total of 72,771 adolescents (15-18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study. Conclusion: Thus, it can be concluded that Covaxin was found to be safe in adolescents (15-18 years). [ABSTRACT FROM AUTHOR]

The Brighton Collaboration (BC) has formulated a number of case definitions which have primarily been applied to adverse events of special interest in the context of vaccine safety surveillance. This is a revision of the 2007 BC case definition for anaphylaxis. Recently, the BC definition has been widely used for evaluating reports of suspected anaphylaxis following COVID-19 vaccination. This has led to debate about the performance of the BC definition in comparison with those from the US National Institute of Allergy and Infectious Disease/Food Allergy Anaphylaxis Network (NIAID/FAAN) and the World Allergy Organization (WAO). BC convened an expert working group to revise the case definition based on their usual process of literature review and expert consensus. This manuscript presents the outcome of this process and proposes a revised case definition for anaphylaxis. Major and minor criteria have been re-evaluated with an emphasis on the reporting of observable clinical signs, rather than subjective symptoms, and a clearer approach to the ascertainment of levels of certainty is provided. The BC case definition has also been aligned with other contemporary and international case definitions for anaphylaxis. [ABSTRACT FROM AUTHOR]

ObjectiveTo compare the incidence of adverse events following immunization （AEFI） between vaccination with 13-valent pneumococcal polysaccharide conjugate vaccine （PCV13） alone and with other vaccines at the same time.MethodsWe obtained PCV13 vaccination adverse reaction reports for children vaccinated in Shanghai between 2017‒2021 from the National Immunization Program Information Management System and collected the information and the data of children vaccinated with PCV13 from The Shanghai vaccination information system. We compared the incidence of adverse reactions between stand-alone and simultaneous vaccination.ResultsA total of 11 175 PCV13 AEFI cases after stand-alone vaccination and 215 PCV13 AEFI cases after simultaneous vaccination were reported during 2017‒2021 in Shanghai， and the incidence rates were 1 252.34/105 and 1 455.75/105， respectively. ORV was the one mostly vaccinated with PCV13 at the same time， and the AEFI incidence was 1 706.67/105. The most reported symptom was fever after PCV13 vaccination， no matter by stand-alone and simultaneous vaccination with the respective incidence rates of 876.69/105 and 1 442.21/105.ConclusionIn general， PCV13 vaccinated with other vaccines at the same time slightly increases the incidence of AEFI.

Nuru Abdu,1 Asmerom Mosazghi,1 Tedros Yehdego,2 Eyasu H Tesfamariam,3 Mulugeta Russom4– 6 1Department of Medical Sciences, Pharmacy Unit, Orotta College of Medicine and Health Sciences, Asmara, Eritrea; 2Expanded Program on Immunization, Family and Community Health Division, Department of Public Health, Asmara, Eritrea; 3Biostatistics and Epidemiology Unit, Department of Statistics, Mai-Nefhi College of Science, Mai-Nefhi, Eritrea; 4Eritrean Pharmacovigilance Centre, National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea; 5Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, the Netherlands; 6European Program for Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux, Bordeaux, FranceCorrespondence: Nuru Abdu, Department of Medical Sciences, Pharmacy Unit, Orotta College of Medicine and Health Sciences, Asmara, Eritrea, Tel +291 7-262928, Email pharmacistnuru@gmail.comBackground: Though vaccines are generally considered extremely safe and effective, they have been associated with some serious adverse events following immunization (AEFIs). AEFIs might be related to either the vaccine, immunization error, anxiety related to immunization, and/or coincidental events. If they are not reported and investigated in timely fashion, they can create rumors and confidence gaps. In the last few years, reporting AEFIs in the Central Region of Eritrea, compared to other regions, has been found to be very low, with the root cause for this variation unknown, making intervention strategies challenging. This study was conducted to assess nurse practitioners’ knowledge and perceptions on AEFI surveillance and barriers to reporting in the region.Methods: An analytical cross-sectional study was conducted among all nurse practitioners who were directly or indirectly involved in immunization services working in all health facilities of the region. Data were collected between October 2019 and February 2020 using an interview-based questionnaire. Percentages and medians (IQR) were used as descriptive statistics, and Mann–Whitney and Kruskal–Wallis tests were used as inferential tools.Results: A total of 130 respondents with a median age of 40 (IQR 23) years were included in the study. The overall median (IQR) knowledge score of the respondents on AEFI surveillance was 87.50 (19) out of 100. Furthermore, median (IQR) comprehensive perception score was 70 (20) out of 100 (range 40– 95). Shortage of motivation and not knowing how to report were identified as the main barriers to reporting AEFIs.Conclusion: Knowledge and perceptions of nurse practitioners in the Central Region on AEFI surveillance were generally encouraging. They should however need to be further trained on the basics of AEFI surveillance to bridge the identified barriers to reporting.Keywords: adverse event following immunization, nurse practitioners, knowledge, perception, barriers, Eritrea

Background: Since the deployment of Coronavirus Disease 2019 (COVID-19) vaccines, skepticism about the safety, incidence, and severity of Adverse Events Following Immunization (AEFI) was a concern. The study has two main objectives. First, to analyze AEFIs following COVID-19 vaccines (Pfizer-BioNTech, AstraZeneca, Sputnik, and Sinopharm) during the vaccination campaign in Lebanon and correlate them with age and gender. Second, to correlate Pfizer-BioNTech and AstraZeneca vaccines' AEFI with the dose administered. Methods: A retrospective study was carried out between February 14th, 2021, and February 14th, 2022. AEFI case reports received to the Lebanese Pharmacovigilance (PV) Program were cleaned, validated, and analyzed using SPSS software. Results: A total of 6808 AEFI case reports were received to the Lebanese PV Program during the period of this study. Case reports were mostly received from females (60.7%) and from vaccine recipients aged 18–44 years. As for the vaccine type, AEFIs occurred more frequently with the AstraZeneca vaccine compared to the Pfizer-BioNTech vaccine. The latter had AEFIs mainly following dose 2, whereas AEFIs with the AstraZeneca vaccine were more frequently reported after dose 1, with general body pain being the most reported systemic AEFI with PZ (34.6%), while fatigue was the most reported AEFI with AZ vaccine (56.5%). Conclusions: The AEFI reported with COVID-19 vaccines in Lebanon were aligned with those reported worldwide. The incidence of rare serious AEFIs should not discourage the public from getting vaccinated. Further studies are needed to evaluate their long-term potential risk. [ABSTRACT FROM AUTHOR]

Introduction: In a large-scale immunization program, there are concerns that there will be errors in the immunization program by health workers, such as in terms of storage or at the time of injecting vaccines. This raises a problem regarding the occurrence of adverse events following immunization (AEFI) experienced by people after vaccination. Considering that the government is the party that organizes the immunization program and procures vaccines, technically, the party that administers or injects the vaccine is the health worker. Methods: This research is doctrinal legal research using a conceptual approach and a statute approach. Results: AEFI is a medical event related to vaccine effects or effects, toxicity, side reactions, pharmacological or program errors, co-occurrence, injection reactions, or undetermined causal relationship. The increase in AEFI cases requires the government's role in handling efforts to reduce the number of AEFI cases. Monitoring and evaluation in the implementation of the immunization program is an infection necessary attempt to assess whether the activities have been carried out following applicable regulations. In addition, this activity must be able to identify aspects that cause cases of vaccine recipients experiencing AEFI. Conclusions:: Health workers can be personally responsible for their mistakes in administering vaccines. The government's responsibility is related to compensating people who suffer from AEFI as a form of government protection for their citizens. [ABSTRACT FROM AUTHOR]

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Background: On March 30, 2020, coronavirus disease 19 was declared pandemic and many countries of the world started working on the development of vaccine soon after China released the genetic structure of severe acute respiratory syndrome coronavirus 2. Drugs Controller General of India on January 3, 2021, accorded emergency use authorization to Oxford-AstraZeneca's ChAdOx1 nCoV-19 vaccine and vaccination drive commenced in India on January 16, 2021. The present study was conducted to determine the incidence adverse event following immunization (AEFI) among recipients of the first and second dose of the vaccine. Materials and Methods: A longitudinal descriptive study was conducted among 2529 vaccine beneficiaries who were asked about the side effects at 24 and 72 h after the first dose and second dose of vaccination with ChAdOx1 nCoV-19 vaccine. Passive surveillance was also done for 4 months. Results: AEFI was reported in 27.59%, 38.4%, and 19.96% of vaccines after both doses, first dose, and second dose, respectively. 14% did not report any AEFI with either dose of vaccine. Younger people had higher rates of AEFIs with both the doses. Pain at injection site and fever

Background: Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax), and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine the type and management of immediate adverse events following immunisation (I-AEFI) after COVID-19 vaccination. Methods: Retrospective review of I-AEFI recorded between July 2021 and June 2022 in 314 community pharmacies in Australia. Results: I-AEFI were recorded in 0.05% (n = 526/977,559) of all COVID-19 vaccinations (highest: AstraZeneca (n = 173/161,857; 0.11%); lowest: Pfizer (n = 50/258,606; 0.02%)). The most common reactions were: (1) syncope, after the first dose of AstraZeneca (n = 105/67,907; 0.15%), Moderna (n = 156/108,339; 0.14%), and Pfizer (n = 22/16,287; 0.14%); and (2) Nausea/vomiting after the first dose of Pfizer (n = 9/16,287; 0.06%), Moderna (n = 55/108,339; 0.05%), and AstraZeneca (n = 31/67,907; 0.05%) vaccines. A total of 23 anaphylactic reactions were recorded (n = 23/977,559; 0.002%), and 59 additional I-AEFI were identified using MedDRA® terminology. Pharmacists primarily managed syncope by laying the patient down (n = 227/342; 66.4%); nausea/vomiting was managed primarily by laying the patient down (n = 62/126; 49.2%), giving water (n = 38/126; 30.2%), or monitoring in the pharmacy (n = 29/126; 23.0%); anaphylactic reaction was treated with adrenaline (n = 18/23; 78.3%) and n = 13/23 (56.5%) anaphylactic reactions were treated with the combination of: administered adrenaline, called ambulance, and laid patient down. Conclusion: The most commonly recorded I-AEFI was syncope after COVID-19 vaccination in pharmacy; I-AEFI are similar to those previously reported. Pharmacists identified and managed serious and non-serious I-AEFI appropriately and comprehensively. [ABSTRACT FROM AUTHOR]

Background: On March 30, 2020, coronavirus disease 19 was declared pandemic and many countries of the world started working on the development of vaccine soon after China released the genetic structure of severe acute respiratory syndrome coronavirus 2. Drugs Controller General of India on January 3, 2021, accorded emergency use authorization to Oxford-AstraZeneca's ChAdOx1 nCoV-19 vaccine and vaccination drive commenced in India on January 16, 2021. The present study was conducted to determine the incidence adverse event following immunization (AEFI) among recipients of the first and second dose of the vaccine. Materials and Methods: A longitudinal descriptive study was conducted among 2529 vaccine beneficiaries who were asked about the side effects at 24 and 72 h after the first dose and second dose of vaccination with ChAdOx1 nCoV-19 vaccine. Passive surveillance was also done for 4 months. Results: AEFI was reported in 27.59%, 38.4%, and 19.96% of vaccines after both doses, first dose, and second dose, respectively. 14% did not report any AEFI with either dose of vaccine. Younger people had higher rates of AEFIs with both the doses. Pain at injection site and fever <102°F were the most common symptoms. Only three patients required admission after first dose and nil required admission after second dose, all three were discharged after 24 h observation without any complication or sequelae. Conclusion: The results of our study indicate that the vaccine has good safety profile and is recommended for use among 18–60 years. However, since majority of individuals in our study were young, studies may be undertaken in more than 60 years of age, persons with a history of allergy, and comorbidities to further evaluate safety profile of the vaccine among these groups of people. [ABSTRACT FROM AUTHOR]

• We evaluated people with suspected hypersensitivity after COVID-19 vaccination. • 92% of 180 referred for hypersensitivity reactions were recommended for revaccination. • 85% with physician-diagnosed hypersensitivity had no recurrent symptoms after revaccination. • Patients with COVID-19 vaccine hypersensitivity reactions can be safely revaccinated. COVID-19 vaccination has been associated with anaphylaxis and hypersensitivity reactions. Infectious disease physicians and allergists in the Canadian Special Immunization Clinic (SIC) Network developed guidance for evaluating patients with adverse events following immunization (AEFI) including suspected hypersensitivity. This study evaluated management and adverse event recurrence following subsequent COVID-19 vaccinations. Individuals aged 12 years and older enrolled at participating SICs before February 28, 2023 who were referred for suspected or diagnosed hypersensitivity reaction following COVID-19 vaccination, or for prevaccination assessment of suspected allergy to a COVID-19 vaccine component were included. De-identified clinical assessments and revaccination data, captured in a centralized database, were analyzed. The Brighton Collaboration case definition (BCCD) for anaphylaxis (2023 version) was applied. The analysis included 206 participants from 13 sites: 26 participants referred for pre-vaccination assessment and 180 participants referred for adverse events following COVID-19 vaccination (15/180 [8.3%] with BCCD confirmed anaphylaxis, 84 [46.7%] with immediate hypersensitivity symptoms not meeting BCCD, 33 [18.3%] with other diagnosed hypersensitivity reactions, and 48 [26.7%] participants with a final diagnosis of non-hypersensitivity AEFI). Among participants referred for AEFIs following COVID-19 vaccination, 166/180 (92.2%) were recommended for COVID-19 revaccination after risk assessment, of whom 158/166 (95.2%) were revaccinated (all with a COVID-19 mRNA vaccine). After revaccination, 1/15 (6.7%) participants with prior anaphylaxis, 1/77 (1.3%) with immediate hypersensitivity not meeting criteria for anaphylaxis and 1/24 (4.2%) with other physician diagnosed hypersensitivity developed recurrent AEFI symptoms that met the BCCD for anaphylaxis. All 26 participants referred pre-vaccination, including 9 (34.6%) with history of polyethylene glycol-asparaginase reactions, were vaccinated without occurrence of immediate hypersensitivity symptoms. Most individuals in this national cohort who experienced a hypersensitivity event following COVID-19 vaccination and were referred for specialist review were revaccinated without AEFI recurrence, suggesting that specialist evaluation can facilitate safe revaccination. [ABSTRACT FROM AUTHOR]

Coronavirus disease 2019 (COVID-19) vaccine administration started in February 2021 in Japan. As of December 2021, approximately 75% of the population aged ≥12 years had received two doses of vaccine. We conducted a study to investigate vasovagal reactions (VVR) after COVID-19 vaccination using data on adverse events following immunization. The crude reporting rate of VVR (cases/1,000,000 doses) after vaccination was 9.6 in all age groups combined, and was more frequent in the younger age groups: 28.6 and 37.2 in individuals aged 10–19 years and 20–29 years, respectively. In individuals aged 10–29 years, the rate was similar in males and females (33.0 and 34.2, respectively, p = 0.53); but was higher after dose 1 than after dose 2 (57.4 and 8.8, respectively, p < 0.001). Based on these results, caution needs to be exercised when vaccinating adolescents and young adults, especially with dose 1 of COVID-19 vaccines. [ABSTRACT FROM AUTHOR]

With dermatologic side effects being fairly prevalent following vaccination against COVID‐19, and the multitude of studies aiming to report and analyze these adverse events, the need for an extensive investigation on previous studies seemed urgent, in order to provide a thorough body of information about these post‐COVID‐19 immunization mucocutaneous reactions. To achieve this goal, a comprehensive electronic search was performed through the international databases including Medline (PubMed), Scopus, Cochrane, Web of science, and Google scholar on July 12, 2021, and all articles regarding mucocutaneous manifestations and considerations after COVID‐19 vaccine administration were retrieved using the following keywords: COVID‐19 vaccine, dermatology considerations and mucocutaneous manifestations. A total of 917 records were retrieved and a final number of 180 articles were included in data extraction. Mild, moderate, severe and potentially life‐threatening adverse events have been reported following immunization with COVID vaccines, through case reports, case series, observational studies, randomized clinical trials, and further recommendations and consensus position papers regarding vaccination. In this systematic review, we categorized these results in detail into five elaborate tables, making what we believe to be an extensively informative, unprecedented set of data on this topic. Based on our findings, in the viewpoint of the pros and cons of vaccination, mucocutaneous adverse events were mostly non‐significant, self‐limiting reactions, and for the more uncommon moderate to severe reactions, guidelines and consensus position papers could be of great importance to provide those at higher risks and those with specific worries of flare‐ups or inefficient immunization, with sufficient recommendations to safely schedule their vaccine doses, or avoid vaccination if they have the discussed contra‐indications. [ABSTRACT FROM AUTHOR]

Methods: Vaccine safety surveillance is increasingly becoming a critical area in national immunization programs. Uganda conducted a Measles-Rubella catchup and Polio mass vaccination campaign between 16 and 20 October 2019. We conducted a descriptive analysis of the adverse events following immunization reported following this campaign to inform policy updates. The target age-group for the campaign was children aged 9 months to 14 completed years, while the target age-group for polio campaign was 0-59 months. We conducted active search for the serious adverse event following immunization that were reported. Results: Among the 19,241,348 persons vaccinated during the Measles-Rubella catch-up and Polio mass campaign, 10,612,278 (55%) received MR vaccine alone; while 8,629,070 (45%) received either bivalent oral polio vaccine (bOPV) alone or MR and bOPV for children 9 to 59 months. The mean age of the children was 8.3 years, range 0.5-14 years, including 68 (47%) boys, 64 (44%) girls and 13 (9%) missing sex classification. The serious adverse events following immunization (AEFI) included; toxic epidermal necrolysis 3 (2.1%), Steven Johnson syndrome 2 (1.4%), severe anemia 2 (1.4%), febrile illness 1 (0.7%), sudden respiratory failure 1 (0.7%), bullous impetigo 1 (0.7%) and injection abscess 19 (13%). Conclusion: AEFI reporting in Uganda is low, and concerted efforts need to be undertaken to create community awareness about the importance of reporting. Additionally, the health care systems should be strengthened to efficiently investigate all potential signals that led to quality causality assessment of serious and other AEFI of public health concern so as to provide correct information to the community and prevent false association of vaccines and or vaccination to incorrect signals, and build a resilient immunization program that is trusted by the community. [ABSTRACT FROM AUTHOR]

Background: Vaccination has been described as the most critical tool to end the COVID-19 pandemic and to save lives and livelihoods. This study aimed to evaluate the spectrum of adverse events following immunization with the COVID-19 AstraZeneca/Oxford vaccine in Ibadan, south western Nigeria. Methodology: A cross-sectional study. Adults aged > 18 years who had received the Astra-Zeneca/Oxford COVID-19 vaccine at selected COVID-19 vaccination centres across three Local Government Areas in Ibadan, SW Nigeria were interviewed by means of a structured questionnaire to determine the spectrum of adverse events following immunisation (AEFI). Results: We enrolled 369 adults; 179 males and 190 females, with a mean of age of 37.8 ± 12.0 years. Three hundred and thirty two (90.0%) of the subjects experienced one or more AEFI. Of the total AEFIs reported, the most frequent were headache 225 (21.1%), fatigue/tiredness 186 (17.4%), pain at the injection site 99 (9.3%) and myalgia 97(9.1%). Nine in ten (96.4%) of these AEFIs occurred within 48 hours postvaccination. Higher severity of adverse events score (p=0.049) and multiple AEFIs (p=0.01) were associated with the first dose of the vaccine. There were severe AEFI in 1.2 % (95% CI: 0.3-.9.0%) of the respondents. Presumed or confirmed COVID 19 infection before vaccination increased the odds of AEFI (OR 7.0,95% CI: 1.8-27.8). Conclusion: Our study showed a high frequency of AEFI among recipients of the Astra Zenecca/Oxford vaccine in Ibadan. Majority of the AEFIs are mild and self-limiting.Previous infection with COVID-19 appears to increase the risk of AEFI. [ABSTRACT FROM AUTHOR]

The BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited. We conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines. After the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40–69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine. Adverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine. [ABSTRACT FROM AUTHOR]

Introduction: The World Health Organization (WHO) recommends measles vaccination campaigns as an effective strategy that is required to halt and revert the burden of measles worldwide, especially in the African region. This is a review of the 2017/2018 measles campaign in South-south Zone, Nigeria. Methods: The WHO EPI cluster survey methodology was used to survey a total of 1260 households covering 1355 children aged 9-59 months, yielding a sufficient sample size to provide estimated zonal and state measles vaccine coverage. Data collection was done using census and survey program software and supplementary immunization activity module of vaccination coverage quality indicators while the analysis was run on Stata. Results: The measles vaccination and routine immunization coverage in the South-south zone of Nigeria were 87.6% and 67.6% respectively. While town criers/mobilizers (49.6%) were the commonest source of information for the campaign, the lack of awareness (28.4%) was the most important reason given by the mothers and care-givers for non-vaccination. Fever (6.6%) was the most commonly reported adverse event following the immunization. Conclusion: The zonal vaccination coverage was less than the WHO recommended coverage that would be needed to stop the measles epidemic in Nigeria. Town criers were very useful for information dissemination. The lack of awareness was a major reason for non-vaccination.

Purpose: COVID-19 immunizations are novel and there is widespread public concern for the lack of data on their potential adverse effects. Cases of Bell's palsy following COVID-19 vaccination were reported disproportionately in the vaccine group during phase 3 clinical trials and have now been reported multiple times post-licensure. The U.S. Food and Drug Administration has stated the frequency of Bell's palsy in the vaccine group is consistent with the expected background rate of Bell's palsy in the population but recommends “surveillance for cases of Bell's palsy with deployment of the vaccine into larger populations.“1 Here we present a case of Bell's palsy following Pfizer/BioNTech BNT162b2 COVID-19 vaccine administration in an HIV+ patient as a potential adverse event following immunization. Observations: A 60-year-old male with HIV presented to the emergency department for evaluation of left facial droop. He had received the first dose of Pfizer/BioNTech BNT162b2 vaccination approximately 42 hours prior to symptom onset. Physical examination in the ED revealed left-sided facial weakness with involvement of the forehead, inability to raise left eyebrow, and inability to close left eye with sensation and strength intact in bilateral upper and lower extremities. Physical examination in our outpatient ophthalmology clinic on day 2 following symptom onset was revealing for mild exposure keratopathy, 5 mm lagophthalmos and very poor Bell's reflex in the left eye with otherwise normal exam findings. These findings were judged to be consistent with uncomplicated Bell's palsy. He was provided ophthalmic lubricating ointment to use hourly, artificial tears as needed, moisture goggles and suggested to tape eyelids nightly in addition to standard systemic glucocorticoid and antiviral therapy. The patient's facial weakness and exposure keratopathy were completely resolved at approximately 90 days following symptom onset. Conclusions: Though there is insufficient evidence at this time to support any causal association between COVID-19 vaccines and Bell's palsy, the temporal relationship between vaccination and classic clinical features of Bell's palsy in our patient certainly raises suspicion for association with Pfizer/BioNTech BNT162b2 COVID-19 vaccination. It will be important to monitor for cases of Bell's palsy following COVID-19 immunization as an increasing percentage of the global population receives vaccination.

On 28 April 2021, the investigation team of the Department of Disease Control, Ministry of Public Health, was notified of a cluster of people developing neurological symptoms following COVID-19 vaccination in a province in eastern Thailand. We conducted an investigation from 29 April to 20 May 2021 to confirm the outbreak, describe the epidemiological characteristics and identify possible risk factors. A matched case-control study was conducted. Matching factors were gender and vaccination site. A confirmed case was a person receiving COVID-19 vaccination in the province and developed at least one neurological symptom between 21 April and 20 May 2021. The rapid assessment of the vaccination cold chain system was carried out. We found a total of 36 cases out of 3920 vaccinees (attack rate = 0.92%), all cases were recovered and classified as an immunization stress-related reaction (ISRR) by the National AEFI Expert Committee. An analytic study found that menstruation was significantly associated with ISRR (AOR = 6.84 [95%CI = 1.09–42.91]). The environmental survey suggested that the cold chain system was properly managed. Further studies on other precipitating causes of ISRR should be performed. In terms of recommendation, health providers should pay greater attention to women menstruating during and after COVID-19 immunization. [ABSTRACT FROM AUTHOR]

COVID-19 vaccines have been speedily developed and deployed. The more vaccine doses are delivered to users, the more common adverse events following immunization (AEFI) are reported. This study aimed to identify factors affecting AEFI in Vietnamese people receiving the COVID-19 vaccine AZD1222 developed by AstraZeneca and Oxford University. In July 2021, an online cross-sectional survey was conducted among Vietnamese who have been vaccinated with COVID-19 vaccines. The questionnaire collected demographic characteristics, medical history, types of injected vaccines, common AEFI, and post-vaccination activities from respondents. The effects of host-related factors on AEFI including 24 specific symptoms were also explored. After screening, 1028 participants who were Vietnamese, over 18 years old and received at least one dose of AZD1222, were included in the study. Only 40/1028 (3.9%) participants reported not having any AEFI, whereas 25/1028 (2.4%) reported to have severe symptoms. The most common AEFI were moderate fever (69.4%), muscle aches (68.6%), followed by fatigue/ sleepiness (62.5%), body aches (59.4%), headache (58.5%), pain at injection site (58.3%) and chills (45.7%). Data analysis showed that females complained about AEFI particularly gastrointestinal symptoms more frequently than males. Age of participants and number of doses were also important factors affecting AEFI as the increase of age or number of vaccine doses was associated with the decrease of self-reported AEFI frequency. This study provides a detailed assessment of risk factors associated with AEFI in Vietnamese people vaccinated with AZD1222. It seems that gender, age and vaccine doses are important factors affecting AEFI. [ABSTRACT FROM AUTHOR]

Abstract Background The occurrence of adverse events following immunization (AEFI) in national immunization programmes is very rare; however, if they occur causality assessment is conducted to identify the associated cause. In the report, we describe a case of severe necrotizing fasciitis in the left arm of a 9-month old boy following administration of the measles vaccine. Case presentation A 9-month old boy presented with swelling on the left upper arm and adjoining the chest area, low-grade continuous fever, frequent passage of loose watery stool and persistent cries 24 h after measles vaccine was administered on the left upper arm. On examination, he was mildly pale, febrile, anicteric. Extensive erythema of the left upper arm occurred thereafter with extensive scalded skin lesions involving the deltoid area, the upper chest wall and arm. This was followed by desquamation of the affected areas and severe necrosis. A diagnosis of severe necrotizing fasciitis was made. A causality assessment was conducted by the state AEFI committee using the detailed AEFI investigation forms to identify the cause of the incidence. Conclusion Here we present a rare case of necrotizing fasciitis which could have been caused by incorrect use of reconstituted measles vaccine. Hence we recommend training of routine immunization service providers on proper vaccine management as well as intensified supervision of immunization sessions.

Introduction: Subcutaneous nodules are a rare adverse event following immunization (AEFI). Reported cases have frequently been associated with aluminum-containing vaccines. Despite the development of a consensus definition of a subcutaneous nodule from the Brighton Collaboration in 2004, there continues to be variation in definitions used in published literature. Areas covered: We reviewed the literature regarding subcutaneous nodule etiology, definition, clinical features, management, and approach to future immunizations. Embase and MEDLINE databases were searched with relevant MeSH terms initially on 8 November 2016, the same searches were repeated on 9 September 2018 prior to finalizing this review. We reviewed published case reports and larger studies reporting subcutaneous nodules and also reviewed articles discussing broader use of aluminum in immunizations and AEFIs. Expert commentary: Consensus from clinicians regarding the approach to management of subcutaneous nodules is vital. We believe that the safety concerns regarding aluminum causing subcutaneous nodules are far outweighed by the benefits of vaccines containing aluminum. Ultimately, supporting subsequent immunizations in individuals that develop nodules needs to be a priority.

Background: Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax), and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine the type and management of immediate adverse events following immunisation (I-AEFI) after COVID-19 vaccination. Methods: Retrospective review of I-AEFI recorded between July 2021 and June 2022 in 314 community pharmacies in Australia. Results: I-AEFI were recorded in 0.05% (n = 526/977,559) of all COVID-19 vaccinations (highest: AstraZeneca (n = 173/161,857; 0.11%); lowest: Pfizer (n = 50/258,606; 0.02%)). The most common reactions were: (1) syncope, after the first dose of AstraZeneca (n = 105/67,907; 0.15%), Moderna (n = 156/108,339; 0.14%), and Pfizer (n = 22/16,287; 0.14%); and (2) Nausea/vomiting after the first dose of Pfizer (n = 9/16,287; 0.06%), Moderna (n = 55/108,339; 0.05%), and AstraZeneca (n = 31/67,907; 0.05%) vaccines. A total of 23 anaphylactic reactions were recorded (n = 23/977,559; 0.002%), and 59 additional I-AEFI were identified using MedDRA® terminology. Pharmacists primarily managed syncope by laying the patient down (n = 227/342; 66.4%); nausea/vomiting was managed primarily by laying the patient down (n = 62/126; 49.2%), giving water (n = 38/126; 30.2%), or monitoring in the pharmacy (n = 29/126; 23.0%); anaphylactic reaction was treated with adrenaline (n = 18/23; 78.3%) and n = 13/23 (56.5%) anaphylactic reactions were treated with the combination of: administered adrenaline, called ambulance, and laid patient down. Conclusion: The most commonly recorded I-AEFI was syncope after COVID-19 vaccination in pharmacy; I-AEFI are similar to those previously reported. Pharmacists identified and managed serious and non-serious I-AEFI appropriately and comprehensively.

Objective: To study the adverse events following immunization (AEFI) with Covishield, a coronavirus disease– 2019 (COVID-19) vaccine. Materials and Methods: A prospective observational study was conducted among 422 Covishield vaccinees based on the inclusion and exclusion criteria after the institutional ethics committee approval. They were followed up at the end of 1 and 2 weeks following the first dose of Covishield vaccine, and the details of adverse events were collected. AEFIs were classified using system organ classification, World Health Organization-Uppsala Monitoring Center (WHO-UMC) causality assessment, AEFI causality assessment, and Modified Hartwig Severity Scale. Various classifications of AEFI were analyzed using descriptive statistics. ANOVA and independent t-test were used for age group and gender comparison of the duration and number of AEFI, respectively. Results: Around 625 AEFIs were reported by 422 vaccinees. Majority of the vaccinees (62.8%) developed adverse events on the day of vaccination. The mean duration of AEFI was 2.52 ± 0.871 days. On WHO-UMC causality assessment, 98.08% were found to be probable, 1.12% possible, and 0.8% unclassifiable. AEFI causality assessment revealed 98.88% vaccine product-related reactions and 1.12% anxiety-related reactions. Regarding the severity, 83.52% of AEFIs were mild and 16.32% were moderate. On comparison of mean duration of AEFI (P = 0.298) and mean number of AEFI (P = 0.569) between different age groups, no statistical significance was observed. Conclusion: The majority of AEFIs reported in this study were mild to moderate in severity for a short duration. The protection offered against the deadly disease and its complication potentially outweighs the mild AEFIs or inconvenience caused by them. Hence, covid-19 vaccination is an important tool to break the pandemic chain. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic, caused by SARS-CoV-2, has had a profound impact worldwide, leading to widespread morbidity and mortality. Vaccination against COVID-19 is a critical tool in controlling the spread of the virus and reducing the severity of the disease. However, the rapid development and deployment of COVID-19 vaccines have raised concerns about potential adverse events following immunization (AEFIs). Understanding the temporal and spatial patterns of these AEFIs is crucial for an effective public health response and vaccine safety monitoring., Objective: This study aimed to analyze the temporal and spatial characteristics of AEFIs associated with COVID-19 vaccines in the United States reported to the Vaccine Adverse Event Reporting System (VAERS), thereby providing insights into the patterns and distributions of the AEFIs, the safety profile of COVID-19 vaccines, and potential risk factors associated with the AEFIs., Methods: We conducted a retrospective analysis of administration data from the Centers for Disease Control and Prevention (n=663,822,575) and reports from the surveillance system VAERS (n=900,522) between 2020 and 2022. To gain a broader understanding of postvaccination AEFIs reported, we categorized them into system organ classes (SOCs) according to the Medical Dictionary for Regulatory Activities. Additionally, we performed temporal analysis to examine the trends of AEFIs in all VAERS reports, those related to Pfizer-BioNTech and Moderna, and the top 10 AEFI trends in serious reports. We also compared the similarity of symptoms across various regions within the United States., Results: Our findings revealed that the most frequently reported symptoms following COVID-19 vaccination were headache (n=141,186, 15.68%), pyrexia (n=122,120, 13.56%), and fatigue (n=121,910, 13.54%). The most common symptom combination was chills and pyrexia (n=56,954, 6.32%). Initially, general disorders and administration site conditions (SOC 22) were the most prevalent class reported. Moderna exhibited a higher reporting rate of AEFIs compared to Pfizer-BioNTech. Over time, we observed a decreasing reporting rate of AEFIs associated with COVID-19 vaccines. In addition, the overall rates of AEFIs between the Pfizer-BioNTech and Moderna vaccines were comparable. In terms of spatial analysis, the middle and north regions of the United States displayed a higher reporting rate of AEFIs associated with COVID-19 vaccines, while the southeast and south-central regions showed notable similarity in symptoms reported., Conclusions: This study provides valuable insights into the temporal and spatial patterns of AEFIs associated with COVID-19 vaccines in the United States. The findings underscore the critical need for increasing vaccination coverage, as well as ongoing surveillance and monitoring of AEFIs. Implementing targeted monitoring programs can facilitate the effective and efficient management of AEFIs, enhancing public confidence in future COVID-19 vaccine campaigns., (©Yiming Li, Jianfu Li, Yifang Dang, Yong Chen, Cui Tao. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 15.07.2024.)

Vaccines against COVID-19 (and its emerging variants) are an essential global intervention to control the current pandemic situation. Vaccines often cause adverse events; however, the vast majority of adverse events following immunization (AEFI) are a consequence of the vaccine stimulating a protective immune response, and not allergic in etiology. Anaphylaxis as an AEFI is uncommon, occurring at a rate of less than 1 per million doses for most vaccines. However, within the first days of initiating mass vaccination with the Pfizer-BioNTech COVID-19 vaccine BNT162b2, there were reports of anaphylaxis from the United Kingdom and United States. More recent data imply an incidence of anaphylaxis closer to 1:200,000 doses with respect to the Pfizer-BioNTech vaccine.In this position paper, we discuss the background to reactions to the current COVID-19 vaccines and relevant steps to mitigate against the risk of anaphylaxis as an AEFI. We propose a global surveillance strategy led by allergists in order to understand the potential risk and generate data to inform evidence-based guidance, and thus provide reassurance to public health bodies and members of the public.

T-cell receptor excision circle levels are a surrogate marker of T-cell production and immune system function. We sought to determine whether non-pathological levels of infant T-cell receptor excision circles were associated with adverse events following immunization. A self-controlled case series design was applied on a sample of 231,693 children who completed newborn screening for severe combined immunodeficiency in Ontario, Canada between August 2013 and December 2015. Exposures included routinely administered pediatric vaccines up to 15 months of age. Main outcomes were combined health services utilization for recognized adverse events following immunization. 1,406,981 vaccination events were included in the final dataset. 103,007 children received the Pneu-C-13 or Men-C-C vaccine and 97,998 received the MMR vaccine at 12 months of age. 67,725 children received the varicella immunization at 15 months. Our analysis identified no association between newborn T-cell receptor excision circle levels and subsequent health services utilization events following DTa-IPV-Hib, Pneu-C-13, and Men-C-C vaccinations at 2-month (RI 0.94[95%CI 0.87-1.02]), 4-month (RI 0.82[95%CI 0.75-0.9]), 6-month (RI 0.63[95%CI 0.57-0.7]) and 12-month (RI 0.49[95%CI 0.44-0.55]). We also found no trends in health services utilization following MMR (RI 1.43[95%1.34-1.52]) or varicella (RI 1.14[95%CI 1.05-1.23]) vaccination. Our findings provide further support for the safety of pediatric vaccinations.

Abstract Background This case report describes a patient with pericarditis likely attributed to influenza vaccination (positive rechallenge), with a literature review. Case presentation A 87-year old patient developed pericarditis after influenza vaccination, with acute chest pain, without ECG abnormalities or increased cardiac enzyme levels. Echocardiogram showed moderate pericardial effusion. Recovery was obtained through steroids One year later, few days after re-immunization, the patient experienced the same symptoms and was admitted to hospital with diagnosis of recurrence of pericarditis with severe pericardial effusion, again treated with steroids. Other possible causes were ruled out and the cardiologist recommended against influenza vaccinations in the future; the patient did not experience recurrence of pericarditis in the following 6 years. Cases of pericarditis following influenza immunization in the literature were also reviewed. Conclusions Pericarditis following immunization for influenza is very rarely reported in the literature. In a few cases, influenza vaccination seems likely responsible. We suggest considering recent immunization in patient’s history as part of the differential diagnosis in elderly with chest pain.

Abstract Background In children with epilepsy, fever and infection can trigger seizures. Immunization can also induce inflammation and fever, which could theoretically trigger a seizure. The risk of seizure after immunization in children with pre-existing epilepsy is not known. The study objective was to determine the risk of medically attended seizure after immunization in children with epilepsy

Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5–7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful.

Objectives: The objectives of the study were to assess the strengths and weaknesses of inactivated polio vaccine (IPV) practices in Qasimabad, Pakistan. Material and Methods: This cross-sectional survey study was conducted in Hyderabad, Sindh, from June 22, 2017, to September 22, 2017. It included seven expanded programs on immunization (EPI) centers in Taluka Qasimabad, as well as outreach settings. Data were collected through convenience sampling with the help of an EPI Monitoring Checklist and a pre-designed questionnaire. Statistical Package for the Social Sciences version 23.0 was used for the descriptive analysis. Results: Six of the seven health facilities were found to be screening for missed opportunities. During power outages or load shedding, the majority of EPI centers (85.7%) had a backup plan in place. However, the major shortcoming was the failure to obtain parental consent before vaccination by vaccinators at all 7 (100%) EPI centers. At 5 (71.9%) of the centers, outreach activities to vaccinate children were organized, and IPV was only given to infants at 1 (19.2%) of the sessions. The vaccinator opened the vial before using it, and the used IPV vial was not discarded at the end of the outreach session. Because one center’s vaccinator was female (19.2%), and another center’s vaccinator was single (19.2%), no outreach activity was planned at those two locations. Conclusion: This research highlights the benefits and drawbacks of the current EPI program for the IPV vaccine. The presence of EPI centers at all health facilities, as well as the availability of IPV and cold chain equipment, as well as permanent and fully-trained employees, are some of the most important strengths. Lack of pre-service training and adverse events following immunization vaccine training were identified as weaknesses. There are a lack of IPV refresher training, as well as improper arrangements for outreach vaccination sessions, and a lack of transportation for vaccinators. [ABSTRACT FROM AUTHOR]

The success of immunization programs in lowering the incidence of vaccine preventable diseases (VPDs) has led to increased public attention on potential health risks associated with vaccines. As a result, a scientifically rigorous response to investigating reported adverse events following immunization (AEFI) and effective risk communications strategies are critical to ensure public confidence in immunization. Globally, an estimated 257 million people have chronic hepatitis B virus (HBV) infection, which causes more than 686,000 premature deaths from liver cancer and cirrhosis. Hepatitis B vaccination is the most effective way to prevent mother-to-child transmission of HBV infection, especially when a timely birth dose is given within 24 h of birth. However, an infant's risk of dying is highest in the neonatal period, and thus, administering HepB-BD within 24 h of birth overlaps with the most fragile period in an infant's life. A working group formed in July 2016 following the publication of the case reports of the effects on vaccination coverage of media reports of infant deaths after HepB-BD administration in China and Vietnam. The goal of the working group was to create a framework and describe best practices for preparing for and responding to AEFI reported after HepB-BD administration, using existing resources. The framework includes six steps, including three preparation steps and three response steps. This document is written for national and regional immunization program staff. Prior to using the framework for preparation and response to AEFIs reported after HepB-BD administration, staff members should be familiar with how AEFI are detected, reported, and investigated in the country. The document might also be of interest to national regulatory staff members who monitor vaccine safety within the country. [ABSTRACT FROM AUTHOR]

• Sixteen AEFI cases (21%) with symptom or sign of bleeding were reported in 2016–2018. • Six (38%) had intra-cranial haemorrhage; 14 (88%) had bleeding from injection site. • Only one case (6%) had confirmed history of receiving vitamin K at birth. • Three (19%) were classified as late onset VKDB; 11 (69%) as suspected late onset VKDB. • Nine cases (56%) resulted in death; among cases with VKDB diagnosis, eight (57%) died. Surveillance for adverse events following immunization (AEFI) is important to monitor vaccine safety and should lead to appropriate responses to improve health and immunization program. Bleeding following vaccination is not recognized as an important AEFI. Without policy of vitamin K (VK) prophylaxis at birth, vitamin K deficiency bleeding (VKDB) could be an important cause of bleeding in young infants and may manifest as AEFI. We retrospectively analysed all serious AEFI cases that presented with external or internal bleeding reported to Nepal's AEFI surveillance system during 2016–2018. The cases were classified as VKDB, suspected VKDB or non-VKDB. During the period, 16 serious AEFI with symptom or sign of bleeding were reported representing 21.3% of all serious AEFI reported. Cases were between 40 and 94 days of age. The National AEFI Investigation Committee classified all cases as coincidental. Fourteen cases (87.5%) had bleeding from injection site. Median time from vaccination to injection site bleeding was 4.3 h (interquartile range: 2.1–11.6 h). Six cases (37.5%) had intra-cranial haemorrhage. Only one case had confirmed history of receiving VK at birth. Ten cases (62.5%) received appropriate treatment (VK injection; blood transfusion if needed). Based on limited laboratory investigations available, three cases (18.75%) could be classified as late onset VKDB and 11 cases (68.75%) as suspected late onset VKDB. VKDB should be suspected in young infants presenting with bleeding including following vaccination, and prompt treatment should be initiated. Bleeding following vaccination should be recognized as an important AEFI as even a small amount of blood loss in young infants can be catastrophic. We posit that this series is a small subset of VKDB cases in Nepal detected through AEFI surveillance system. In countries without policy of VK prophylaxis at birth including Nepal, the policy should be introduced. [ABSTRACT FROM AUTHOR]