Post-vaccination Adverse Events Research Articles

Heterologous prime-boost with the mRNA-1273 vaccine among CoronaVac-vaccinated healthcare workers in Indonesia.

PurposeThis study was performed to investigate humoral immune response and adverse events upon the heterologous prime-boost with a single dose of the mRNA-1273 vaccine among fully CoronaVac-vaccinated, infection-naïve healthcare workers in Indonesia.Materials and MethodsOne hundred twenty-five eligible healthcare workers were recruited from one hospital for this prospective cohort study. Blood collection was conducted twice, i.e., on 7 days before and 28 days after the booster vaccination. The titer of anti-SARS-CoV-2 receptor-binding domain (RBD) antibodies was quantified accordingly. The post-vaccination adverse event was recorded for both CoronaVac and mRNA-1273 vaccinations. Any breakthrough infection was monitored during the follow-up period. Wilcoxon matched-pairs signed rank test was used to test differences between groups.ResultsA significant increase was observed in the titer of anti-SARS-CoV-2 RBD antibodies upon receiving the mRNA-1273 booster (geometric mean titers of 65.57 and 47,445 U/mL in pre- and post-booster, respectively), supporting the argument to use heterologous prime-boost vaccination to improve the protection against COVID-19 in a high-risk population. The mRNA-1273 vaccine, however, caused a higher frequency of adverse events than the CoronaVac vaccine. Nonetheless, the adverse events were considered minor medical events and temporary as all subjects were not hospitalized and fully recovered. Of note, no breakthrough infection was observed during the follow-up to 12 weeks post-booster.ConclusionThe heterologous prime-boost vaccination of healthcare workers with a single dose of the mRNA-1273 vaccine generated a significant elevation in humoral immune response towards RBD of SARS-CoV-2 and was associated with a higher frequency, but minor and transient, adverse events.

Adverse Events Following COVID-19 Vaccination in Rivers State, Nigeria: A Cross-Sectional Study.

Coronavirus disease (COVID-19) has led to over 2,589,638 deaths globally as of March 2021 and speedy discovery of vaccines. Nigeria started the phase one COVID-19 vaccination in March 2021 using the Oxford AstraZeneca vaccine. Reports of severe adverse events with the Oxford AstraZeneca vaccine resulted in its suspension in some countries necessitating the need to determine its safety. To assess the prevalence, types and severity of the adverse events following COVID-19 vaccination in Rivers State, Nigeria. A cross-sectional study design was adopted. Simple random sampling method was used to select a total of 428 adults from recipients of the first dose of COVID-19 vaccine within 28 days of vaccination. A questionnaire adapted from World Health Organisation was interviewer-administered through phone calls; responses were recorded on Kobo Toolbox. Descriptive analysis of variables was done and the association between adverse events and age, allergy and medical history were determined. The level of statistical significance was predetermined at a P < 0.05. In this study, 50.5% of respondents reported post-vaccination adverse events out of which 10 (4.6%) were severe (30% of the severe cases were life-threatening, 60% were hospitalised and 10% were placed on bed rest). The most common side effects were fever (73.0%), pain at the injection site (41.2%), fatigue (33.3%), body ache (17.5%) and headache (13.8%). No significant association was observed between the incidence of severe adverse events and participants with allergies or medical history. The adverse events associated with the COVID-19 vaccine were largely mild and resolved within a few days. Further research is required to classify adverse events into categories.

KEJADIAN MIOKARDITIS PASCA PEMBERIAN VAKSIN COVID-19 BERBASIS mRNA

COVID-19 is still being a pandemic with high morbidity and mortality rate. In Indonesia, there were about 4 million cases with 150 thousand of them ending up in death. The approved COVID-19 vaccines have been successful in decreasing their morbidity and mortality rate, with mRNA-based vaccines such as BNT162b2 and mRNA-1273 having high efficacy. There are reports about the post-vaccination adverse events such as myocarditis, therefore a literature review was written about the problem. This article was made as a literature review, collecting previous research articles about myocarditis induced by the mRNA COVID-19 vaccine. Data collecting was done subjectively, without using any structured planning systematic and narratively presented. There are seven research articles investigating post-vaccination myocarditis, which 5 of them concluded about an increased risk of myocarditis event due to mRNA vaccine, one article stated that mRNA vaccine whether it is BNT162b2 or mRNA-1273, is safe to be used, and one article stated there is no correlation between myocarditis and mRNA vaccination due to a very small incident rate. mRNA COVID-19 vaccines are safe to be used due to their high efficacy in preventing severe clinical manifestations of SARS-CoV-2 infection. A post-vaccination adverse event like myocarditis is very rare and has a temporary and mild clinical manifestation in nature.

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

Background: The 2019 novel coronavirus (2019-nCoV or SARS-CoV-2) was first detected in December 2019 in Wuhan City of Hubei, Province of China with population of 11 million, after outbreak of pneumonia. Present study deals with acceptability of newly manufactured vaccines against Covid 19 disease component of social misconceptions regarding the post vaccination symptoms and/or adverse events. Main rationale of this study is to list all post vaccination symptoms observed at multiple points of time to clear misconceptions resulting in possible increase in acceptability of newer vaccines.&#x0D; Aim: To determine the spectrum of symptoms observed followed by administration of 1st and 2nd doses of COVISHIELD™ vaccine in Datta Meghe Institute of Medical Sciences (deemed to be university).&#x0D; Methods: This will be a Prospective analytical cohort study conducted over a period of 5 years. &#x0D; Procedure: Followed by letter of informed consent, pre validated questionnaire will be circulated amongst the healthcare professionals having been administered the 1st and 2nd doses of COVISHIELD™ vaccine filled and submitted to authorized email for further study and will be evaluated for enlisting post vaccination symptoms with time of onset and duration following 1st and 2nd doses of COVISHIELD™ vaccine. Follow up will maintained at regular intervals and questionnaire will be amongst participants at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after the 2nd dose of COVISHIELD™ vaccine.&#x0D; Expected Outcome: Post vaccination symptoms following 1st and 2nd doses of COVISHIELD™ vaccine with range of time of onset and duration of the same will enhance status of the COVISHIELD™ vaccine awareness, social acceptability and willingness.&#x0D; Conclusion: All conclusions will be drawn after proper statistical analysis.

Adverse events of inactivated COVID-19 vaccine in HIV-infected adults

This study aims to evaluate the safety of inactivated COVID-19 vaccine among adult people living with HIV (PLWH). In total, 259 PLWH who received at least one dose of inactivated COVID-19 vaccine were enrolled, and post-vaccination adverse events (AEs) were evaluated seven days following each vaccination dose. The overall AE frequency was 22.8% after dose one, which was higher than after dose two (10.2%) (P < 0.001). No severe side event or vaccine safety concern was observed. Our finding was essential in reducing vaccine hesitancy among PLWH.

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

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

Sentimentos de pré-adolescentes e adolescentes quanto í vacinação contra o papilomavirus humano

Objetivo: identificar os sentimentos de pré-adolescentes e adolescentes quanto í vacinação contra o papilomavirus humano. Método: trata-se de um estudo fenomenológico, com abordagem qualitativa, realizado com 10 participantes, sendo pré- adolescentes e adolescentes, cujas quais foram vacinadas na sala de vacina de uma Unidade Básica de Saúde de um municí­pio de Minas Gerais. Os depoimentos foram gravados e transcritos na í­ntegra para posterior análise. O tratamento dos dados se deu por meio de Análise de Conteúdo. Resultados: a maioria das entrevistadas atribuiu í significação da vacinação relacionada ao fato de prevenir o câncer de colo uterino. O desconhecimento sobre a finalidade da vacina HPV fica em evidência em alguns depoimentos. O medo da vacina também ficou em evidência, tendo como justificativa o fato de ser injeção, da dor, da agulha e por medo da reação. Como medidas de prevenção, foram citadas o uso de preservativo e a ida periódica ao ginecologista. Seis das participantes não souberam informar nenhuma medida de prevenção contra o papilomavirus humano. Conclusão: as participantes do estudo entendem a importância da vacinação contra o papilomavirus humano, embora seis participantes, bem como suas famí­lias, informaram ter receio pela dor da vacinação ou possí­veis eventos adversos pós-vacinais.

Post-vaccination adverse events in the elderly in the State of São Paulo, Brazil, 2015 to 2017

Vaccination is one of the public health measures that has most contributed to decreasing the incidence of vaccine-preventable diseases. However, vaccines can lead to post-vaccination adverse events. This study thus aimed to analyze the prevalence of post-vaccination adverse events in elderly persons, determine the reported post-vaccination adverse events, identify the vaccines that cause post-vaccination adverse events, and verify the post-vaccination adverse events and vaccines that lead to hospitalizations in the State of São Paulo, Brazil, from 2015 to 2017. This was a descriptive cross-sectional study with a quantitative approach based on notifications of post-vaccination adverse events recorded in the Information System of the National Immunization Program. The results showed that of the 15,196,080 elderly persons that were immunized, there were 207 reports of post-vaccination adverse events, of which 187 (89%) were non-serious adverse events and 15 (8%) due to immunization errors (IE). The majority of the patients were female (86%), white (49%), and from 60 to 69 years of age (70%). Clinical manifestations featured local reactions at the injection site (84%). There were 131 cases (64%) that evolved to cure without sequelae. Two individuals (2%) were hospitalized due to serious adverse events. The first had received adult diphtheria/tetanus (dT), pneumococcal (Pn23), and influenza vaccines, and the second had received Pn23. The post-vaccination adverse events notifications showed incomplete information. In conclusion, notification of post-vaccination adverse events is essential. Health professionals need to be committed to adequate completion of the notification forms, with health surveillance supervision aimed at quality of care for elderly persons with post-vaccination adverse events.

Reactogenicity after the first and second doses of BNT162b2 mRNA coronavirus disease vaccine: a single-center study.

PurposeThis study was conducted to determine differences in adverse events associated with the first and second doses of the BNT162b2 coronavirus disease 2019 vaccine based on the age and sex of recipients.Materials and MethodsAn online survey on the post-vaccination adverse events of healthcare workers was conducted from March 2021 to April 2021. The differences in the types of adverse events, including severity, onset time, and duration of symptoms, and how the adverse events were dealt with by the patient were analyzed based on the age and sex. The profiles of adverse events were compared after the first and second vaccination doses.ResultsAmong the 131 participants who participated in the online survey out of 208 vaccine recipients, 43 and 80 recipients of the BNT162b2 vaccine experienced adverse events after the first and second dose, respectively. No sex-related differences were observed in the profiles of adverse events in vaccinated recipients. The overall frequency of adverse events did not differ based on age after the first dose. After the second dose, the frequency of adverse events, including both local and systemic reactions was significantly higher in the younger age group than in the older age group.ConclusionThe BNT162b2 vaccine resulted in a higher frequency of adverse events after the second dose than after the first dose especially in the younger age group; however, no sex-related differences associated with these adverse events were observed.

Eventos adversos pós-vacinais papilomaví­rus humano em adolescentes

Avaliar a ocorrência dos eventos adversos pós-vacinais em adolescentes relacionados í vacina quadrivalente Papilomaví­rus Humano 6, 11, 16 e 18 (recombinante) através do Sistema de Informações do Programa Nacional de Imunizações Eventos Adversos Pós-Vacinação da Coordenadoria de Saúde da írea Programática 5.1 procedentes das Unidades Básicas de Saúde. A amostra foi composta por adolescentes entre 9 a 17 anos de idade. Estudo retrospectivo, de caráter exploratório, descritivo e quantitativo no perí­odo de 01 de novembro de 2016 até 01 de junho de 2019. Analisadas no estudo 22 fichas de notificações, sendo 19 de eventos adversos pós-vacinais e 3 Erros de Imunização (EI). Os eventos adversos nos adolescentes estão relacionados a ansiedade e medo frente a vacinação, ocorridos na administração da primeira dose da vacina HPV, predominante no sexo masculino, ocorrendo nos primeiros 30 minutos após administração do imunobiológico. Nesta pesquisa, os eventos adversos com maiores frequências, foram classificados como não graves, com evolução para cura sem sequelas, relacionados í manifestações como a palidez, hipotensão, desmaio e sí­ncope.

Educação permanente em sala de imunização: elaboração de manual de normas e rotinas

Objetivo do estudo é construir um manual de normas e rotinas para a sala de imunização. Pesquisa metodológica, realizado em outubro a dezembro de 2019 e teve como foco o desenvolvimento uma ferramenta que possa ser utilizado como forma de educação permanente em saúde pela equipe atuante dentro da sala de imunização. Para tal, foram realizadas quatro etapas, sendo: levantamento bibliográfico, seleção de conteúdo, elaboração textual e diagramação. O estudo teve como resultado a elaboração de um manual intitulado “Manual de Normas e Rotinas para a Sala de Imunização”, que destaca temáticas sobre equipe da sala de vacina, acolhimento, higiene das mãos, câmara fria, estabilidade dos imunobiológicos, organização da sala, impressos e manuais utilizados dentro do setor, calendário vacinal 2019/2020, contraindicações vacinais, eventos adversos pós-vacinação, profilaxia contra raiva humana, centro de imunobiológicos especiais, cuidados pós-vacinação e referências utilizadas para a construção do manual. Destaca-se que por se tratar de uma ferramenta de baixo custo, se espera que este estudo possa auxiliar na prática correta na administração e gerenciamento das salas de vacinas.

A statistical analysis of vaccine-adverse event data

BackgroundVaccination has been one of the most successful public health interventions to date, and the U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) currently contains more than 500,000 reports for post-vaccination adverse events that occur after the administration of vaccines licensed in the United States. The VAERS dataset is huge, contains very large dimension nominal variables, and is complex due to multiple listing of vaccines and adverse symptoms in a single report. So far there has not been any statistical analysis conducted in attempting to identify the cross-board patterns on how all reported adverse symptoms are related to the vaccines.MethodsFor studies of the relationship between vaccines and reported adverse events, we consider a partial VAERS dataset which includes all reports filed over a period of 24 years between 1990-2013. We propose a neighboring method to process this dataset for dealing with the complications caused by multiple listing of vaccines and adverse symptoms in a single report. Then, the combined approaches based on our neighboring method and novel utilization of data visualization techniques are employed to analyze the large dimension dataset for characterization of the cross-board patterns of the relations between all reported vaccines and events.ResultsThe results of our analysis indicate that those events or symptoms with overall high occurrence frequencies are positively correlated, and those most frequently occurred adverse symptoms are mostly uncorrelated or negatively correlated under different bacteria vaccines, but they are in many cases positively correlated under different virus vaccines, especially under flu vaccines. No particular patterns are shown under live vs. inactive vaccines.ConclusionsThis article identifies certain cross-board patterns of the relationship between the vaccines and the reported adverse events or symptoms. This helps for better understanding the VAERS data, and provides a useful starting point for the development of statistical models and procedures to further analyze the VAERS data.

Adverse events following immunization against influenza the in elderly in Brazil

To identify and analyze the occurrence of adverse events after vaccination against influenza in Brazilian elderly. Descriptive, analytical, retrospective and quantitative research on 98 elderly people identified through post-vaccination adverse event reporting forms provided by the Post-Vaccination Adverse Events Information System of Minas Gerias, Brazil, between 2014 and 2016. Data were double-entered and transferred to the software Ri386 version 3.4.3 3 IBM SPSS Statics version 25. Descriptive statistics, frequency and percentages were used for qualitative variables, and measures of central tendency (mean and median) and dispersion (standard deviation) were used for numerical variables. In order to verify the association between the types of events (non-severe, severe and immunization error) and systemic manifestations with elderly and vaccine characterization variables, Fisher's exact and Chi-square tests were used; the significance level was p <0.05. Of the elderly studied, 75.5% were female, predominantly Caucasian (55.1%), whose age ranged from 60 to 97 years; 84.7% of adverse events were described as non-adverse events, with local manifestations in 64.3% and systemic manifestations in 27.6%. Providing specific information to nurses regarding pre- and post-vaccination care against influenza is highly relevant for establishing adequate care that is harmless to the elderly and that lead to avoidable adverse events.

Safety of the rVSV ZEBOV vaccine against Ebola Zaire among frontline workers in Guinea

BackgroundAs part of the ring vaccination trial in Guinea, Front Line Workers were invited to participate in a sub-study to provide additional information on the immunogenicity and safety of rVSVΔG/ZEBOV-GP. Here we summarize the information on the safety follow-up. MethodsAn open-label, non-randomized, immunogenicity evaluation of one dose of rVSVΔG/ZEBOV-GP was conducted in Conakry, Guinea between March 2015 and July 2016. Front-line workers refusing vaccination were invited to participate as a control group. Participants were followed for 3 months with a subset followed-up for 6 months after vaccination. Women becoming pregnant during the follow-up were followed until pregnancy outcome. Solicited and unsolicited adverse events were monitored at each contact with participants using standardized study forms. Results2016 vaccinated participants and 99 controls were included in the safety cohort. On the 3 days post-vaccination visit adverse events were very common, with over 70% of participants reporting at least one adverse event. The most frequently reported symptoms were headache, fatigue, arthralgia, subjective fever and myalgia. Among participants that completed fever diaries (n = 887), post-vaccination fever was reported by 15.22%. Comparing to the unvaccinated group, local reaction, fatigue, headache, arthralgia, myalgia and subjective fever occurring within the first 3 days post-vaccination were statistically significantly different in the vaccinated group compared to the unvaccinated. A total of 8 Serious Adverse Events were identified during follow-up. 2 SAEs were related to pregnancy. ConclusionsResults confirm that adverse events 3 days after vaccination with the rVSV candidate vaccine are common. The occurrence of fever is of particular concern in the context of ongoing Ebola transmission. Additional studies should address important data gaps regarding the use of the vaccine in pregnancy and other vulnerable populations.

Safety of live-attenuated measles-mumps-rubella and herpes zoster vaccination in multiple myeloma patients on maintenance lenalidomide or bortezomib after autologous hematopoietic cell transplantation

Attenuated live virus vaccinations are generally recommended 24 months following hematopoietic cell transplantation (HCT) in patients not receiving immunosuppressive therapy. To date, there are no data regarding the safety of live-attenuated herpes zoster or measles-mumps-rubella (MMR) vaccinations in multiple myeloma patients on maintenance lenalidomide or bortezomib following autologous HCT. One hundred thirty-seven multiple myeloma patients on maintenance lenalidomide or bortezomib post-auto-HCT who received either MMR or herpes zoster vaccine were analyzed and any adverse events documented in the medical record in the 42 days following vaccination were recorded. Patients were vaccinated a median of 25 months (range, 18-62) post transplant. The most common post-vaccination adverse event was upper respiratory tract infection (18/137 patients); no rash attributed to vaccine strains or other adverse outcomes potentially related to the vaccines were identified. MMR and herpes zoster vaccination were safe and well-tolerated in this cohort.

Pain caused by measles, mumps, and rubella vaccines: A systematic literature review.

The risk of post-vaccination adverse events (AEs) is a primary public health concern. Among the AEs, pain is a significant source of anxiety for both children and their parents. This review describes and assesses the intensity of pain experienced by children post-vaccination with widely used Measles-Mumps-Rubella (MMR) vaccines. A systematic literature search was conducted in Pubmed, Embase and Cochrane to identify publications describing immediate pain at injection site (primary objective) or pain within days (secondary objective) after 2 specific MMR vaccines. Immediate pain ('acute pain' according to the Brighton Collaboration case definition) was defined as pain occurring at the time or within 5min of injection. Four studies, which compared the intensity of immediate injection site pain experienced by children after MMR vaccination, were identified. Various pain assessment tools and methods were used to quantify the intensity of pain, including the median difference in Visual Analog Scale scores between vaccine groups. All four studies showed significantly less immediate pain caused by Priorix (GSK Vaccines) compared with M-M-R II (Merck & Co., Inc.). To our knowledge, this review summarizes for the first time the available scientific evidence on the intensity of pain following different MMR vaccines. It highlights that MMR vaccines can differ in terms of immediate pain. Further research may be needed to better understand the underlying reason for this observation. In this context, it is very important to understand which physicochemical properties are most relevant for the immediate pain profile of a vaccine to thereby support the development of vaccines with the best possible immediate pain profile.

Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature.

The human papillomavirus (HPV) vaccine is efficacious in preventing complications of human papillomavirus infection including cervical cancer. However, there have been case reports of adverse events occurring after vaccination, one being postural orthostatic tachycardia syndrome (POTS). This article reviews published data and other available information regarding the relationship between the human papillomavirus vaccine and POTS. Background information is provided regarding the human papillomavirus vaccine and the proposed post-vaccination adverse event POTS. Peer-reviewed literature, statements by government and medical advisory committees, and publicly available information published on this topic are examined. At this time, there is no conclusive evidence supporting a causal relationship between the human papillomavirus vaccine and POTS. Though a causal relationship has been postulated, it is of utmost importance to recognize that while temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population.

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine and Commonly Administered Vaccines After Coadministration

Given the broad age range across which the quadrivalent meningococcal conjugate vaccine MenACWY-CRM is used, coadministration with routine vaccines should be evaluated across age groups for possible immunologic interference and impact on vaccine reactogenicity and safety. We summarize data from a large population of infants, adolescents and international travelers from 10 phase 3 or 4 clinical studies to evaluate coadministration of MenACWY-CRM with commonly administered vaccines. Noninferiority analyses of immune responses were performed across studies and age groups for each vaccine. Reactogenicity and safety were also assessed. In infants, MenACWY-CRM coadministered with routine vaccines did not reduce immune responses to diphtheria, tetanus, poliovirus, hepatitis B, Haemophilus influenzae type b, pneumococcal conjugate, measles-mumps-rubella, varicella or pertussis antigens. Noninferiority criteria were not met for some pneumococcal conjugate serotypes at 7 months of age, but no consistent trends were observed. In adolescents, coadministration did not reduce immune responses to tetanus, diphtheria and human papilloma virus vaccine antigens. Noninferiority criteria for pertussis antigens were not uniformly met in infant and adolescent studies, although the clinical relevance is unclear. In adults, coadministration did not reduce immune responses to hepatitis A/B, typhoid fever, yellow fever, Japanese encephalitis and rabies antigens. Immune responses to MenACWY-CRM were not impacted by coadministration of commonly administered vaccines. Coadministration did not increase frequencies of postvaccination adverse events in any age group. With no clinically relevant vaccine interactions or impact on vaccine reactogenicity or safety, these results support the coadministration of MenACWY-CRM with routine vaccines in all age groups.

Post-Vaccination Adverse Events in Korean Children Reported by their Parents

This study purpose is to examine the types and patterns of post-vaccination adverse events perceived by parents with infants and young children ultimately in order to monitor adverse events suspected to be associated with vaccines and to provide basic information for developing measures against such adverse events. From June 2006 to June 2013, 415 cases reporting experiences of vaccine adverse events in infants and young children were extracted and data were analyzed through content analysis. Among the vaccines perceived by parents with infants and young children to cause adverse events, DTaP-IPV was most frequent as found in 317 cases, which was followed by PCV/Hib in 259 cases, and BCG in 136 cases. As to the type of adverse events, after the vaccination of DTaP, 55 cases of ‘skin reactions’, 51 cases of ‘fever of over 39°C, and 45 cases of ‘digestive disorders’ including vomiting and diarrhea. After the vaccination of PCV/Hib, 62 cases of ‘fever’ happened, 54 cases of ‘skin reactions’, and 36 cases of ‘fretfulness or restlessness’. After the vaccination of BCG, ‘lymphadenitis over 1cm’ was most frequent as reported in 77 cases, and 21 cases of ‘skin reactions’ appeared. Finally, it is believed necessary to make efforts to reduce post-vaccination adverse events through the safe management of vaccine, thorough preliminary checkup of the child’s condition before vaccination, and careful observation after vaccination. And there should be continuous long-term follow-up and research on causality for post-vaccination adverse events.

The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review.

BackgroundProphylactic antipyretic administration decreases the post-vaccination adverse reactions. Recent study finds that they may also decrease the antibody responses to several vaccine antigens. This systematic review aimed to assess the evidence for a relationship between prophylactic antipyretic administration, post-vaccination adverse events, and antibody response in children.MethodsA systematic search of major databases including MEDLINE and EMBASE was carried out till March 2014. Randomized controlled trials (RCTs) comparing prophylactic antipyretic treatment versus placebo post-vaccination in children ≤6 years of age were included. Two reviewers independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data [PROSPERO registration: CRD42014009717].ResultsOf 2579 citations retrieved, a total of 13 RCTs including 5077 children were included in the review. Prophylactic antipyretic administration significantly reduced the febrile reactions (≥38.0°C) after primary and booster vaccinations. Though there were statistically significant differences in the antibody responses between the two groups, the prophylactic PCM group had what would be considered protective levels of antibodies to all of the antigens given after the primary and booster vaccinations. No significant difference in the nasopharyngeal carriage rates (short-term and long-term) of H. influenzae or S. pneumoniae serotypes was found between the prophylactic and no prophylactic PCM group. There was a significant reduction in the local and systemic symptoms after primary, but not booster vaccinations.ConclusionsThough prophylactic antipyretic administration leads to relief of the local and systemic symptoms after primary vaccinations, there is a reduction in antibody responses to some vaccine antigens without any effect on the nasopharyngeal carriage rates of S. pneumoniae & H. influenza serotypes. Future trials and surveillance programs should also aim at assessing the effectiveness of programs where prophylactic administration of PCM is given. The timing of administration of antipyretics should be discussed with the parents after explaining the benefits & risks.