Vaccine Pharmacovigilance: A Review of The Current Practices

Review Article | DOI: https://doi.org/10.31579/2690-1897/267

Vaccine Pharmacovigilance: A Review of The Current Practices

  • Chinmyee Saha,
  • Ishita Zalavadiya *

Research Scholar Department of Pharmacology, School of pharmacy, RK University Rajkot, India

*Corresponding Author: Ishita Zalavadiya, Assistant Professor Department of Pharmacology, School of pharmacy, RK University, Rajkot, India.

Citation: Chinmyee Saha, Ishita Zalavadiya, (2025), Closing Gaps, Saving Lives: Molecular Diagnostics for Cervical Cancer Worldwide Chinmyee saha, J, Surgical Case Reports and Images, 8(7); DOI:10.31579/2690-1897/267

Copyright: © 2025, Ishita Zalavadiya. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 11 July 2025 | Accepted: 13 August 2025 | Published: 19 August 2025

Keywords: public health; infectious disease; pharmacovigilance; active surveillance; adverse events

Abstract

 Vaccines have played a crucial role in preventing infectious diseases for decades, leading to the control and eradication of numerous harmful pathogens. They have a profound impact on public health by significantly reducing illness, disability, and mortality rates worldwide. The importance of vaccines lies in their ability to activate the immune system to recognize and respond effectively to specific pathogens. By stimulating the production of antibodies and memory cells, vaccines strengthen the body's defense mechanism. This not only protects individuals who are immunized but also contributes to the development of herd immunity, safeguarding those who cannot be vaccinated due to certain medical conditions. While vaccines undergo rigorous testing and regulatory approval before introduction into the market, ongoing pharmacovigilance remains essential in monitoring their safety and promptly identifying any adverse events. Pharmacovigilance encompasses the processes of collecting, analyzing, and assessing data related to vaccines' safety profiles. This surveillance system enables the detection of rare or unexpected side effects, facilitating timely risk management strategies and ensuring public confidence in vaccination programs. Pharmacovigilance activities include passive reporting systems, active surveillance programs, and in-depth investigations of adverse events. Adverse events are thoroughly evaluated in terms of their causal relationship with the vaccine, the severity of the event, and the affected population groups. This report discusses Crucial role in public health by preventing the spread of infectious diseases, Different methods are used to monitor vaccines' safety and effectiveness, including post-marketing surveillance studies, spontaneous reporting systems, and active surveillance through various healthcare databases. 

1.Introduction

One of the most effective methods for preventing and managing infectious diseases is vaccination. They function by inducing the production of antibodies and memory cells by the immune system, which are then able to identify and neutralise the microorganisms that cause disease. Immunisations can prevent the transmission of diseases and develop herd immunity, which can benefit both the recipients and the communities in which they reside. Vaccines do not, however, come without hazards or limitations. Certain vaccinations might not work for everyone or might become less effective over time. Some people may experience mild to severe adverse reactions or side effects from some immunisations. Certain vaccines may cause problems in terms of ethics or society, or they may interfere with other medications or medical conditions. Pharmacovigilance for vaccines entails gathering and examining information from a range of sources, including social media, databases, registries, post-marketing surveillance, spontaneous reporting systems, and clinical trials. It also entails informing the relevant parties—health authorities, vaccine producers, medical professionals, and members of the public—with the results and suggestions. The primary goals of vaccine pharmacovigilance are to guarantee the efficacy, safety, and quality of vaccines; to recognise and manage any possible risks or benefits; and to encourage the best possible use of vaccinations.

With the COVID-19 pandemic hastened the creation and introduction of new vaccinations against the novel coronavirus, pharmacovigilance of vaccines is particularly pertinent. The vaccine's unparalleled speed and scope

2.Definition of Vaccine:

2.Definition of Vaccine: 

Vaccines are biological preparations that strengthen immunity against specific diseases, often given via needle injection or orally or sprayed into the nose. They mimic disease-causing bacteria and help the immune system recognize and eliminate foreign agents, enabling the body to recognize and destroy them. The term "vaccination" comes from cow smallpox. [1]          

3.Types: 

3.1. Live, Attenuated Vaccines: 

Live, attenuated vaccinations, such as those for chickenpox, mumps, and measles, are weakened copies of live germs in the lab that instruct the immune system on how to prevent illness. [2]

Example: Vaccines against measles, mumps, and chickenpox

3.2. Inactivated Vaccines

Scientists create inactivated vaccines by killing disease-causing microbes using chemicals, heat, or radiation, ensuring stability and safety over live vaccines as dead microbes cannot mutate. [2]

Example: Vaccines against influenza, polio, hepatitis A, and rabies. 2. Inactivated Vaccines:

3.3. Subunits Vaccines: 

Subunit vaccines contain essential antigens that stimulate the immune system, using specific epitopes for recognition and binding by antibodies or T cells. [2]

Example: Plague immunization.

3.4. Toxoid Vaccines: 

A toxoid vaccine is used for bacteria causing illness due to bacterial toxins. Toxoids, which can be inactivated with formalin, are safe for use in vaccines due to their detoxification properties. [2]

Example: Crotalus atrox toxoid is used to vaccinate dogs against rattlesnake bites.

3.5. Conjugate Vaccines:

Researchers may develop a conjugate vaccine for harmful bacteria with polysaccharide coatings, which disguise antigens, preventing immature immune systems from responding to them in infants and young children. [2]

Example: Haemophilus influenzae type B vaccine.

3.6.DNA Vaccines: 

DNA vaccines, still in experimental stages, show great promise in human testing. These vaccines dispense the entire organism and its parts, focusing on the essentials of the microbe's genetic material. [2]

Example: Influenza vaccine.

3.7. Recombinant Vector Vaccines: 

Recombinant vector vaccines are experimental vaccines that use an attenuated virus or bacterium to introduce microbial DNA to body cells, similar to DNA vaccines. [2]

Example: DPT

4.Importance of Vaccine:

Vaccinations are crucial for family and public health, preventing the spread of dangerous diseases. The first vaccine was smallpox, which killed 300-500 million people worldwide. After being given, the disease was eradicated, making it the only disease to be completely destroyed. Vaccines can treat various diseases like Measles, Polio, Mumps, Chicken pox, Whooping cough, Diphtheria, HPV, and COVID-19. [2]

                                                                                            Figure 1: Vaccine Disease Prevention -1 [6]

                                                                                                 Figure 2: Vaccine Disease Prevention -2 [6]

5.Safety of Vaccines 

The IOM has criticized vaccine safety due to insufficient knowledge and research capacity, warning that future safety reviews will be hindered if research capacity is not improved. [5]

Clinical Issues 

Evaluation of safety & efficacy in laboratory for vaccines is equally important as other pharmaceutical products before licensure. [3]

Phase 1 trial 

• Require subjects in tens, • Detect extremely common adverse events [3]

Phase 2 trial

Enrolling numerous subjects aids in determining the correlation between antigen, Concentration and vaccine components. [3]

Phase 3 trial 

The study focuses on managing, preventing, or treating vaccine adverse events in the rudimentary stage, requiring subspecialties with adequate referral base, research funds, formulation techniques, dose effects, and common reactions. [3]

6.Methodological Problems

6.1. Signal Detection 

Surveillance systems quickly detect vaccine adverse events by examining multiple exposures and disease outcomes, with sensitivity detecting previously unknown illnesses and specificity tracking known diseases.

6.2. Standard Definitions and Evaluative Protocols – 

Case definitions are used during reporting or analysis to enhance specificity. They reduce processing times, lower operating costs, and reduce surveillance sensitivity. Open-ended reporting forms increase surveillance sensitivity and cost, but hinder scientific knowledge in immunization safety due to lack of standard case definitions.

6.3. Assessment of causality Assessment of vaccine associated adverse events is not possible unless 

Epidemiologic studies are needed to determine if vaccinated individuals are at higher risk for adverse events in the absence of vaccination.

6.4. Exposure 

Documentation of exposure status is crucial to prevent misclassification, but poor documentation due to mobility and difficulty in ascertaining vaccination status, especially in older individuals, may be encountered.

6.5. Outcome

 The Institute of Medicine committee suggests that assessing rare vaccination-related events is a major challenge, with logistical infeasibility and inadequate study power being significant obstacles.

 6.6. Analysis, Confounding and Bias 

Childhood vaccines are typically administered on schedule, but age can be a confounding factor, leading to delayed or non-vaccination due to difficult-to-control factors.

• eg: low socio-economic status.

 7.Currently Available Solutions 

7.1. Pre-licensure 

Large-scale, randomized experimental trials are needed for better vaccine risk assessment, and pre-licensure assessments should be expanded. Data and safety monitoring boards can also be improved. [3]

7.2. Post Licensure 

7.2.1. Spontaneous Reporting Systems (SRS):

Passive surveillance (SRS) is the foundation of vaccine safety monitoring systems due to low costs. Manufacturers maintain SRS for their products, which are forwarded to national regulatory authorities. The administration of vaccines leads to the development of vaccine adverse event reporting systems (VAERS), which are computerized to allow narrative descriptions of adverse events. The World Health Organization has developed guidelines for monitoring adverse events following immunization [3]

 7.3. Classifications & Case Definitions 

Vaccine adverse events can be categorized into frequency, extent, severity, causality, and preventability. [3]

7.4. Recent classification divides adverse events after vaccinations into: 

  • Vaccine-induced 
  • Vaccine-potentiated
  • Programmatic error 
  • Coincidental

7.5. Standardized Clinical Assessment Protocols & Centres: 

 Assessment of Causality Depends on: 

The strength of association, analytical bias, biologic gradient, dose response, statistical significance, consistency, and biologic plausibility/coherence are crucial factors to consider. [3]

7.6 Signal Detection

Identifying potential vaccine safety problems requires clinical intuition and epidemiologic expertise. VAERS is a large registry for rare vaccine adverse events. Bell's palsy was detected in Swiss intranasal influenza vaccine recipients. The proper reporting rate ratio (PRR) method is widely used for disproportionality in VAERS for prospective and retrospective signal generation. [3]

7.7. Mass Immunization Campaigns 

Large vaccine doses administered over short intervals can lead to more prominent clusters of vaccine adverse events. Surveillance during mass immunization campaigns generates signals, either positive or negative, and VAERS data helps identify potential risk factors for vaccine adverse events. [3]

7.8. Clinical Trials 

A) Post-licensure clinical trials 

Clinical trials optimize vaccine use by assessing changes in formulation, strain, age, dose timing, simultaneous administration, and interchangeability of vaccines from different manufacturers post-licensure. [3]

B) Phase 4 Surveillance Studies 

The system enhances the detection of adverse events not detected during pre-licensure trials and assesses potential adverse events based on spontaneous reporting systems, medical literature, or other mechanisms.

• Eg of ad-hoc follow up studies to signals of vaccine safety issues are SIDS after DTP vaccination. D) Automated Large-linked Databases

Automated large link databases could enhance the safety monitoring of post-licensure vaccine changes without conducting clinical trials. [3]

8.Methodological Approaches 

8.1. Exposures 

Vaccination records help track individual vaccine exposure, simplify study design, and assess data accuracy. Automated records streamline logistics and reduce misclassification errors. A centralized National Vaccination Registry can minimize misclassification errors. The CDC's Vaccine Identification Standards Initiative improves information transfer accuracy. [3]

 8.2. Outcomes 

A sequential approach is necessary for high sensitivity and specificity in studies, such as reviewing medical records for neurologic illness following DTP immunization and collecting and analyzing information for insidious outcomes. [3]

8.3. Analysis 

• The case cross over or case series approaches are gaining popularity in vaccine safety studies [3]

8.4. Bias 

• To minimize it is best to rely on data sources that gather information on outcomes and vaccines exposure independently [3]

9.Vaccines Pharmacovigilance:

9.1. Missing Information 

Community understanding of vaccine-preventable diseases risks children's health, loss of disease visibility, lack of urgency, fear, insufficient data, and uninformed individuals may unintentionally spread misinformation [6]. 

9.2. Misinformation 

Unintentional Misinformers and intentional Misinformers actively mislead others, often seeking personal gain. They use sophisticated tools, media's fascination with "controversies," and the internet's power. Many are unaware of diseases and misinformed about vaccine safety risks. [6]

Information about Vaccines and Vaccine Safety Missing Information Can Evolve into Misinformation

9.3. The Evolution of Missing Information into Misinformation About Vaccine Safety Issues-1 

The media raises vaccine safety concerns, leading to confusion among parents. Insufficient information from scientists prevents conclusive proof of vaccine ineffectiveness, causing further scientific uncertainty [6] 

9.4. The Evolution of Missing Information into Misinformation About Vaccine Safety Issues-2 

Public health officials compare potential risks from adverse events with known disease risks, making recommendations to protect public health. Media often reports controversy between officials and parents, with pseudoscience often discounted. New data may suggest a mechanism, but plausibility doesn't establish causality. [6]

9.5. The Evolution of Missing Information into Misinformation About Vaccine Safety Issues-

Scientists consensus on rejecting hypothesis, leading to parents discrediting scientists, media describing controversy, confusion, and potential disease outbreaks due to declining vaccine coverage [6]

9.6. Measles-containing Vaccines and Autism 

In 1998, UK media reported the measles vaccine as a possible cause of autism, but the public health community reassured them, and the IOM Vaccine Safety Committee rejected the association. [6]

9.7. Consequences

UK immunization levels remain low, leading to measles and mumps outbreaks in the UK, Ireland, and Germany, which spread to the US and Canada.

9.8. Thimerosal Misinformation 

Despite numerous studies and a review by the Institute of Medicine, media reports continue to controvertize a'mercury poisoning' treatment for approximately 10,000 children, with delays in immunizations and school exemptions. [4]

10.Role of The Clinician in Vaccine Safety 

Proper storage and administration, identification of contraindications, education, reporting and treatment of reactions, referral as appropriate, and follow-up are crucial aspects of proper medication management.

11. Vaccine Management 

his text covers vaccine storage, administration, dose timing, precautions, side effects management, reporting, communication, administration issues, equipment, and entry site. [11]

11.1 SPECIAL POPULATIONS should talk with a Health Care Provider before getting Flu vaccine 

Individuals with a history of severe vaccine allergies, Guillain-Barre Syndrome, moderate or severe illness, or those experiencing a pandemic may face unique considerations. [10]

11.2. Cdc Vaccine Information Statements 

Public Health law mandates parents/vaccinees to receive vaccine safety information, known side effects, contraindications, reporting adverse events, and vaccine injury compensation at each visit. [12]

11.3 WHEN IS IT SAFE TO IMMUNIZE? 

 Mild illness, disease exposure, antibiotic therapy, breastfeeding, premature birth, allergies, and family history of vaccine reactions are common factors affecting vaccination outcomes [13]

11.4 Vaccine Reactions 

Serious side effects from vaccines are rare, with only 1 to 2 people potentially experiencing severe allergic reactions if given 1 million doses [14]

11.4.1. Signs of a severe allergic reaction can include:

Breathing difficulties, face and throat swelling, fast heartbeat, a bad rash, dizziness, and weakness are common symptoms.

11.4.2. VACCINE REACTIONS What we should do: 

The process involves responding to physical, emotional, and referring needs to specialists, providing information, reassuring, reporting, and following up on the situation [15]

12. Vaccine Injury Compensation Program 

The policy covers childhood vaccines on a no-fault basis, excluding proof vaccines that caused problems or worsened existing health conditions. [16]

12.1. Pre-Licensure Testing 

 Vaccines undergo laboratory tests, animal tests, human clinical trials, and Phase I, II, and III tests to ensure safety, potency, and purity, with each lot undergoing FDA approval before release [17]

12.2. Post-Licensure Monitoring 

The VAERS, VSD Project, CISA Centers, IOM reviews, and registry of adverse events are essential for ensuring vaccine safety and promoting unified national spontaneous reporting. 

• Jointly administered by CDC and FDA since 1990 • Receives more than 20,000 reports per year 1-800-822-7967 www.vaers.hhs.gov  [18]

13.Types of Adverse Events Reported to Vaers 

• Vaccine reaction or side effect 

• Vaccine potentiated 

• Programmatic or human error 

• Coincidental

Yes, No Yes, a b c d No Illness or Syndr ome Establishing Causal Link: Adverse Event & Vaccine Vaccination VAERS = biased cell “a” [18]

14. Vaccine Safety Datalink 

Active surveillance of the US population involves 8 HMOs, covering approximately 2.5% of the population, using large-linked databases, exposure, outcomes, covariates, and scientifically rigorous hypothesis testing. [18]

15. Clinical Immunization Safety Assessment (Cisa)Centers 

The Brighton Collaboration is a clinical research organization focused on studying adverse events following immunization (AEFI), identifying risk factors, and developing evidence-based guidance for clinicians. They also develop globally accepted case definitions and guidelines for vaccine safety data. [18]

15.1. Vaccine Risk Communication 

Mercury-based preservative, thimerosal, was removed or reduced in US vaccines in 2001 due to concerns about flu vaccine safety, but no evidence of harm has been found. [18]

15.2. Why Communicate About Vaccine Risks and Benefits? 

The text states that guidance is necessary, people are seeking information, and legal requirements are being 

Met [20]

15.3. Credibility Ladder 

The list includes health professionals, safety professionals, university scientists, environmental professionals, media, activist groups, industry, federal government, and paid external consultants.

16. ADD Definition 

The CIOMS/WHO Working Group on Vaccine Pharmacovigilance defines vaccine pharmacovigilance as the science and activities related to detecting, assessing, understanding, and communicating adverse events following immunization and other vaccine-related issues, and preventing untoward effects [5]

16.1. Two type of vaccine reaction-

Minor reaction

Symptoms typically occur within hours of injection and resolve quickly. They can be local (pain, swelling, redness) or systemic (fever, malaise, muscle pain, headache, loss of appetite). [20]

Severe reaction

Vaccine-induced seizures and allergic reactions are typically non-life-threatening but can be disabling and rarely life-threatening, involving the body's reaction to a specific vaccine component.

16.2. Which AEFIs should be reported? 

Serious adverse events (AEFI) can occur due to the introduction of a new vaccine, an immunization error, unexplained events within 30 days, significant parental or community concern, and swelling, redness, or soreness at the injection site lasting more than 3 days. [20]

16.3.  Adverse event following immunization (AEFI) 

Vaccine product-related reactions include severe limb swelling after DTP vaccination, due to a defective vaccine. Quality defect reactions involve inactivated vaccines leading to paralytic polio. Immunization error reactions involve infection transmission through contaminated vials. Immunization anxiety reactions result in vasovagal syncope. Coincidental events, like fever caused by malaria, can occur. [20]

16.4 Types of ADR 

• Very common ≥ 10%

 • Common (frequent) ≥ 1% and < 10>

• Uncommon (infrequent) ≥ 0.1% and < 1>

• Rare ≥ 0.01% and < 0>

• Very rare < 0>

16.5. Determining causality 

Determining causation between events linked in time is common in drug and vaccine safety monitoring systems, especially for vaccines. Factors like missing information on "dechallenge and rechallenge," administering vaccines at coincidental age, multiple vaccines at the same visit, and specific conditions for storage, handling, transport, and administration can lead to adverse events. Therefore, investigating immunization errors is 

crucial. [21]

16.6. Rate of ADR occurrence 

The observed rate is the total number of cases reported per 1000 vaccinated children, detected in clinical trials or post-licensure vaccine safety studies. The background rate is not related to the vaccine and occurs per 1000 unvaccinated children. Vaccine reaction rate is related to the vaccine [21].

 16.7. Other factors to consider when comparing rates of AEFIs 

The text outlines the role of vaccine manufacturers, their age range, doses, case definitions, surveillance methods, and the potential differences in background conditions between communities. [21]

16.8. Problem 

A 7-year-old child died from encephalopathy, convulsions, and death during a mass measles campaign targeting 7.5 million children aged 9 months to 14 years. [21]

– Should the measles campaign be suspended? 

– Does the need for action to protect children from possible vaccine related harm in this situation outweigh the need for further investigation, or vice versa?

The immunization campaign could be discontinued, a vaccine batch could be withdrawn, and staff training and communication could be enhanced.

– Advantages: 

Along with lessening vaccine-related anxiety, the campaign also restores trust in the shot's efficacy.

– Disadvantages: 

cost, potential compromise of the campaign, loss of confidence in vaccine quality. 

The audit aims to identify immunization errors in health workers' practices, investigate training needs, and assess future evidence for reconsideration and action monitoring.

 Risk benefit evaluation 

Kanindistan has implemented a mass vaccination campaign against Japanese Encephalitis Virus (JEV) for 15-year-olds, with three million children vaccinated in the first two weeks, resulting in 140 deaths, compared to a 5.25/100,000 mortality rate in the previous year. [21]

Evaluate this information, to determine whether the risk/benefits of the JEV vaccination campaign outweigh the risks of the disease.

Comparing mortality rates of unvaccinated vs. vaccinated children

• With 3 million children vaccinated, the expected mortality in this group in a 2-week period is: 3,000,000 x 120/100,000 x 2/52 = 138 

• The number of deaths (140) is slightly higher than this figure. [21]

 Comparing the risk of children dying from Japanese Encephalitis (JE) with the excess mortality among vaccinated children  

• (140 – 138) / 3,000,000 = 1/1,500,000 vaccinated children.

 • The risk of dying from the disease (5.25/100,000) is greater than the excess mortality associated with the vaccination (1/1,500,000). [21]

17. Vaccine development: 

17.1. Steps on Vaccine Development -1 

The process involves recognizing a disease as a distinct entity, identifying the etiologic agent, growing the agent in a laboratory, establishing an animal model, identifying an immunologic correlate, inactivating or attenuating the agent, preparing a candidate vaccine, and evaluating its effectiveness. [21]

17.2. Steps on Vaccine Development -2 

The process involves preparing protocols for human studies, applying for IND approval, conducting Phase I trials, Phase II trials, and Phase III trials to evaluate safety, immugenicity, and efficacy. [21]

17.3. Steps on Vaccine Development – 3 

The process involves submitting a Product Licensure Application, Advisory Committees review, and Marketing Post-Licensure Surveillance for safety and effectiveness, taking 10-15 years, with high costs of $100-$700 million per successful vaccine [21] 

17.4. Vaccines are Not Without Risk 

No vaccine is 100% safe or effective, and all vaccines have mild to severe side effects, with the risk of disease outweighing the vaccine's risk. [21]

                                                              
 

                                                                                                        Figure 3: Vaccine Adverse Management [21]

17.5 The Provider’s Role  

Immunization providers manage vaccine storage, administration, dose timing, precautions, side effects, reporting suspected side effects, and communicating benefits and risks, considering conditions in recipients that may compromise immunity. [21]

17.6.  Invalid Contraindications to Vaccination 

Mild illness, mild/moderate reactions, fever, antibiotic therapy, disease exposure, convalescence, pregnancy, premature birth, breastfeeding, allergies, and family history unrelated to immunosuppression. [1]

17.7.  Vaccine-Associated Paralytic Polio (VAPP)

OPV is a live attenuated virus, with 1 out of 2.4 million doses VAPP. 1997 introduced an IPV/OPV schedule, and 2000 recommended an all IPV schedule in the US.

18. Pharmacovigilance Methods 

18.1. Objective

The plan aims to establish a robust reporting system for monitoring medicine safety, understanding new medicines' safety profiles, assessing adverse drug reactions, and utilizing electronic health records for 

pharmacovigilance. [20]

18.2. Methods 

Passive surveillance

18.2.1. Spontaneous Reports

A communication from healthcare professionals to regulatory authorities outlines adverse drug reactions, identifying safety signals, rare AEs, at-risk groups, risk factors, and clinical feature.[20]

18.2.2. Case series 

Case reports can support drug-associated adverse events (AEs), generate hypotheses, and provide detailed follow-up for frequent adverse events like anaphylaxis, aplastic anemia, and Stevens-Johnson syndrome.[20]

18.3. Stimulated Reporting 

Online reporting of adverse events (AEs) encourages health professionals to report new products or limited periods, but often results in incomplete data and insufficient accuracy in incidence rates.[20]

18.3. Active surveillance

The goal is to accurately determine the number of adverse events (AEs) through a continuous, organized process, such as patient follow-ups, and to obtain comprehensive data on individual AE reports [20]

18.3.1. Sentinel Sites: -

  Active surveillance in institutions, nursing homes, and hospitals collects data on patient subgroups    and drug abuse [22]

18.3.2. Drug Event Monitoring: - 

Patients are identified through electronic prescription data or health insurance claims, and follow-up questionnaires are sent to physicians and patients, containing demographics, treatment indications, duration, dosage, clinical events, and discontinuation reasons.

Registries: - 

A registry is a list of patients with similar characteristics, such as disease, drug, or pregnancy registry, which differs depending on the patient type.

18.4. Comparative Observational Studies: -

Traditional epidemiologic methods are crucial for assessing adverse events (AEs), while observational study designs validate signals from spontaneous reports or case series [20]

18.4.1. Cross Sectional Studies: -

Data from a single point in time, collected for surveys or ecological analysis, is best used to examine disease prevalence or trends over time when serial data is captured. [20]

18.4.2. Case Control Study: - 

The study identifies a disease, selects controls or patients without the disease or event, and compares their exposure status using odds ratio. [20]

18.4.3. Cohort Study: - 

The study follows a population at risk for a disease, tracking exposure status and incident rates. It selects cohorts based on drug use and investigates multiple adverse events [20]

18.5. Targeted Clinical Investigations: -

Significant risks from pre-approval clinical trials may prompt further studies to evaluate ADR mechanisms, conduct PK and PD studies, and investigate potential drug-drug and food-drug interactions.

18.6. Descriptive Studies: -

This method is primarily used to determine the background rate of outcome events and/or the prevalence of drug use in specific populations.

18.7. Natural History of Disease- 

The study analyzed the natural history of disease, patient characteristics, disease distribution, and potential outcomes' incidence and prevalence in selected populations.

18.8. Drug Utilization Study- 

Studies collect data on specific populations like the elderly, children, and patients with hepatic or renal dysfunction, often stratified by age, gender, medication, and other factors.

19. Adverse Event Communication Vincent, Covello. (2003) 

Respect the opinions of those who believe they have been harmed by immunization. If an adverse event is unfounded, provide a sympathetic explanation. Acknowledge uncertainty, be open about an event, discuss prevention measures, and report all suspected adverse events to the Vaccine Adverse Event Reporting System.

20. Conclusion:

Vaccines have been instrumental in eradicating diseases like smallpox and reducing the prevalence of others like polio and measles, saving millions of lives and improving public health worldwide. They also contribute to herd immunity, protecting vulnerable populations like infants, elderly, and immunocompromised individuals. Pharmacovigilance is a crucial aspect of vaccine research, development, and post-marketing surveillance, involving the detection, assessment, understanding, and prevention of adverse effects or vaccine-related concerns. Governments, regulatory bodies, manufacturers, healthcare professionals, and patients all contribute to pharmacovigilance by reporting adverse events and participating in surveillance activities.

References

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Prof Sherif W Mansour

Dear Hao Jiang, to Journal of Nutrition and Food Processing We greatly appreciate the efficient, professional and rapid processing of our paper by your team. If there is anything else we should do, please do not hesitate to let us know. On behalf of my co-authors, we would like to express our great appreciation to editor and reviewers.

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Hao Jiang

As an author who has recently published in the journal "Brain and Neurological Disorders". I am delighted to provide a testimonial on the peer review process, editorial office support, and the overall quality of the journal. The peer review process at Brain and Neurological Disorders is rigorous and meticulous, ensuring that only high-quality, evidence-based research is published. The reviewers are experts in their fields, and their comments and suggestions were constructive and helped improve the quality of my manuscript. The review process was timely and efficient, with clear communication from the editorial office at each stage. The support from the editorial office was exceptional throughout the entire process. The editorial staff was responsive, professional, and always willing to help. They provided valuable guidance on formatting, structure, and ethical considerations, making the submission process seamless. Moreover, they kept me informed about the status of my manuscript and provided timely updates, which made the process less stressful. The journal Brain and Neurological Disorders is of the highest quality, with a strong focus on publishing cutting-edge research in the field of neurology. The articles published in this journal are well-researched, rigorously peer-reviewed, and written by experts in the field. The journal maintains high standards, ensuring that readers are provided with the most up-to-date and reliable information on brain and neurological disorders. In conclusion, I had a wonderful experience publishing in Brain and Neurological Disorders. The peer review process was thorough, the editorial office provided exceptional support, and the journal's quality is second to none. I would highly recommend this journal to any researcher working in the field of neurology and brain disorders.

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Dr Shiming Tang

Dear Agrippa Hilda, Journal of Neuroscience and Neurological Surgery, Editorial Coordinator, I trust this message finds you well. I want to extend my appreciation for considering my article for publication in your esteemed journal. I am pleased to provide a testimonial regarding the peer review process and the support received from your editorial office. The peer review process for my paper was carried out in a highly professional and thorough manner. The feedback and comments provided by the authors were constructive and very useful in improving the quality of the manuscript. This rigorous assessment process undoubtedly contributes to the high standards maintained by your journal.

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Raed Mualem

International Journal of Clinical Case Reports and Reviews. I strongly recommend to consider submitting your work to this high-quality journal. The support and availability of the Editorial staff is outstanding and the review process was both efficient and rigorous.

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Andreas Filippaios

Thank you very much for publishing my Research Article titled “Comparing Treatment Outcome Of Allergic Rhinitis Patients After Using Fluticasone Nasal Spray And Nasal Douching" in the Journal of Clinical Otorhinolaryngology. As Medical Professionals we are immensely benefited from study of various informative Articles and Papers published in this high quality Journal. I look forward to enriching my knowledge by regular study of the Journal and contribute my future work in the field of ENT through the Journal for use by the medical fraternity. The support from the Editorial office was excellent and very prompt. I also welcome the comments received from the readers of my Research Article.

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Dr Suramya Dhamija

Dear Erica Kelsey, Editorial Coordinator of Cancer Research and Cellular Therapeutics Our team is very satisfied with the processing of our paper by your journal. That was fast, efficient, rigorous, but without unnecessary complications. We appreciated the very short time between the submission of the paper and its publication on line on your site.

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Bruno Chauffert

I am very glad to say that the peer review process is very successful and fast and support from the Editorial Office. Therefore, I would like to continue our scientific relationship for a long time. And I especially thank you for your kindly attention towards my article. Have a good day!

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Baheci Selen

"We recently published an article entitled “Influence of beta-Cyclodextrins upon the Degradation of Carbofuran Derivatives under Alkaline Conditions" in the Journal of “Pesticides and Biofertilizers” to show that the cyclodextrins protect the carbamates increasing their half-life time in the presence of basic conditions This will be very helpful to understand carbofuran behaviour in the analytical, agro-environmental and food areas. We greatly appreciated the interaction with the editor and the editorial team; we were particularly well accompanied during the course of the revision process, since all various steps towards publication were short and without delay".

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Jesus Simal-Gandara

I would like to express my gratitude towards you process of article review and submission. I found this to be very fair and expedient. Your follow up has been excellent. I have many publications in national and international journal and your process has been one of the best so far. Keep up the great work.

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Douglas Miyazaki

We are grateful for this opportunity to provide a glowing recommendation to the Journal of Psychiatry and Psychotherapy. We found that the editorial team were very supportive, helpful, kept us abreast of timelines and over all very professional in nature. The peer review process was rigorous, efficient and constructive that really enhanced our article submission. The experience with this journal remains one of our best ever and we look forward to providing future submissions in the near future.

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Dr Griffith

I am very pleased to serve as EBM of the journal, I hope many years of my experience in stem cells can help the journal from one way or another. As we know, stem cells hold great potential for regenerative medicine, which are mostly used to promote the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives. I think Stem Cell Research and Therapeutics International is a great platform to publish and share the understanding towards the biology and translational or clinical application of stem cells.

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Dr Tong Ming Liu

I would like to give my testimony in the support I have got by the peer review process and to support the editorial office where they were of asset to support young author like me to be encouraged to publish their work in your respected journal and globalize and share knowledge across the globe. I really give my great gratitude to your journal and the peer review including the editorial office.

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Husain Taha Radhi

I am delighted to publish our manuscript entitled "A Perspective on Cocaine Induced Stroke - Its Mechanisms and Management" in the Journal of Neuroscience and Neurological Surgery. The peer review process, support from the editorial office, and quality of the journal are excellent. The manuscripts published are of high quality and of excellent scientific value. I recommend this journal very much to colleagues.

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S Munshi

Dr.Tania Muñoz, My experience as researcher and author of a review article in The Journal Clinical Cardiology and Interventions has been very enriching and stimulating. The editorial team is excellent, performs its work with absolute responsibility and delivery. They are proactive, dynamic and receptive to all proposals. Supporting at all times the vast universe of authors who choose them as an option for publication. The team of review specialists, members of the editorial board, are brilliant professionals, with remarkable performance in medical research and scientific methodology. Together they form a frontline team that consolidates the JCCI as a magnificent option for the publication and review of high-level medical articles and broad collective interest. I am honored to be able to share my review article and open to receive all your comments.

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Tania Munoz

“The peer review process of JPMHC is quick and effective. Authors are benefited by good and professional reviewers with huge experience in the field of psychology and mental health. The support from the editorial office is very professional. People to contact to are friendly and happy to help and assist any query authors might have. Quality of the Journal is scientific and publishes ground-breaking research on mental health that is useful for other professionals in the field”.

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George Varvatsoulias

Dear editorial department: On behalf of our team, I hereby certify the reliability and superiority of the International Journal of Clinical Case Reports and Reviews in the peer review process, editorial support, and journal quality. Firstly, the peer review process of the International Journal of Clinical Case Reports and Reviews is rigorous, fair, transparent, fast, and of high quality. The editorial department invites experts from relevant fields as anonymous reviewers to review all submitted manuscripts. These experts have rich academic backgrounds and experience, and can accurately evaluate the academic quality, originality, and suitability of manuscripts. The editorial department is committed to ensuring the rigor of the peer review process, while also making every effort to ensure a fast review cycle to meet the needs of authors and the academic community. Secondly, the editorial team of the International Journal of Clinical Case Reports and Reviews is composed of a group of senior scholars and professionals with rich experience and professional knowledge in related fields. The editorial department is committed to assisting authors in improving their manuscripts, ensuring their academic accuracy, clarity, and completeness. Editors actively collaborate with authors, providing useful suggestions and feedback to promote the improvement and development of the manuscript. We believe that the support of the editorial department is one of the key factors in ensuring the quality of the journal. Finally, the International Journal of Clinical Case Reports and Reviews is renowned for its high- quality articles and strict academic standards. The editorial department is committed to publishing innovative and academically valuable research results to promote the development and progress of related fields. The International Journal of Clinical Case Reports and Reviews is reasonably priced and ensures excellent service and quality ratio, allowing authors to obtain high-level academic publishing opportunities in an affordable manner. I hereby solemnly declare that the International Journal of Clinical Case Reports and Reviews has a high level of credibility and superiority in terms of peer review process, editorial support, reasonable fees, and journal quality. Sincerely, Rui Tao.

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Rui Tao

Clinical Cardiology and Cardiovascular Interventions I testity the covering of the peer review process, support from the editorial office, and quality of the journal.

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Khurram Arshad

Clinical Cardiology and Cardiovascular Interventions, we deeply appreciate the interest shown in our work and its publication. It has been a true pleasure to collaborate with you. The peer review process, as well as the support provided by the editorial office, have been exceptional, and the quality of the journal is very high, which was a determining factor in our decision to publish with you.

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Gomez Barriga Maria Dolores

The peer reviewers process is quick and effective, the supports from editorial office is excellent, the quality of journal is high. I would like to collabroate with Internatioanl journal of Clinical Case Reports and Reviews journal clinically in the future time.

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Lin Shaw Chin

Clinical Cardiology and Cardiovascular Interventions, I would like to express my sincerest gratitude for the trust placed in our team for the publication in your journal. It has been a true pleasure to collaborate with you on this project. I am pleased to inform you that both the peer review process and the attention from the editorial coordination have been excellent. Your team has worked with dedication and professionalism to ensure that your publication meets the highest standards of quality. We are confident that this collaboration will result in mutual success, and we are eager to see the fruits of this shared effort.

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Maria Dolores Gomez Barriga

Dear Dr. Jessica Magne, Editorial Coordinator 0f Clinical Cardiology and Cardiovascular Interventions, I hope this message finds you well. I want to express my utmost gratitude for your excellent work and for the dedication and speed in the publication process of my article titled "Navigating Innovation: Qualitative Insights on Using Technology for Health Education in Acute Coronary Syndrome Patients." I am very satisfied with the peer review process, the support from the editorial office, and the quality of the journal. I hope we can maintain our scientific relationship in the long term.

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Dr Maria Dolores Gomez Barriga

Dear Monica Gissare, - Editorial Coordinator of Nutrition and Food Processing. ¨My testimony with you is truly professional, with a positive response regarding the follow-up of the article and its review, you took into account my qualities and the importance of the topic¨.

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Dr Maria Regina Penchyna Nieto

Dear Dr. Jessica Magne, Editorial Coordinator 0f Clinical Cardiology and Cardiovascular Interventions, The review process for the article “The Handling of Anti-aggregants and Anticoagulants in the Oncologic Heart Patient Submitted to Surgery” was extremely rigorous and detailed. From the initial submission to the final acceptance, the editorial team at the “Journal of Clinical Cardiology and Cardiovascular Interventions” demonstrated a high level of professionalism and dedication. The reviewers provided constructive and detailed feedback, which was essential for improving the quality of our work. Communication was always clear and efficient, ensuring that all our questions were promptly addressed. The quality of the “Journal of Clinical Cardiology and Cardiovascular Interventions” is undeniable. It is a peer-reviewed, open-access publication dedicated exclusively to disseminating high-quality research in the field of clinical cardiology and cardiovascular interventions. The journal's impact factor is currently under evaluation, and it is indexed in reputable databases, which further reinforces its credibility and relevance in the scientific field. I highly recommend this journal to researchers looking for a reputable platform to publish their studies.

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Dr Marcelo Flavio Gomes Jardim Filho

Dear Editorial Coordinator of the Journal of Nutrition and Food Processing! "I would like to thank the Journal of Nutrition and Food Processing for including and publishing my article. The peer review process was very quick, movement and precise. The Editorial Board has done an extremely conscientious job with much help, valuable comments and advices. I find the journal very valuable from a professional point of view, thank you very much for allowing me to be part of it and I would like to participate in the future!”

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Zsuzsanna Bene

Dealing with The Journal of Neurology and Neurological Surgery was very smooth and comprehensive. The office staff took time to address my needs and the response from editors and the office was prompt and fair. I certainly hope to publish with this journal again.Their professionalism is apparent and more than satisfactory. Susan Weiner

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Dr Susan Weiner

My Testimonial Covering as fellowing: Lin-Show Chin. The peer reviewers process is quick and effective, the supports from editorial office is excellent, the quality of journal is high. I would like to collabroate with Internatioanl journal of Clinical Case Reports and Reviews.

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Lin-Show Chin

My experience publishing in Psychology and Mental Health Care was exceptional. The peer review process was rigorous and constructive, with reviewers providing valuable insights that helped enhance the quality of our work. The editorial team was highly supportive and responsive, making the submission process smooth and efficient. The journal's commitment to high standards and academic rigor makes it a respected platform for quality research. I am grateful for the opportunity to publish in such a reputable journal.

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Sonila Qirko

My experience publishing in International Journal of Clinical Case Reports and Reviews was exceptional. I Come forth to Provide a Testimonial Covering the Peer Review Process and the editorial office for the Professional and Impartial Evaluation of the Manuscript.

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Luiz Sellmann

I would like to offer my testimony in the support. I have received through the peer review process and support the editorial office where they are to support young authors like me, encourage them to publish their work in your esteemed journals, and globalize and share knowledge globally. I really appreciate your journal, peer review, and editorial office.

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Zhao Jia

Dear Agrippa Hilda- Editorial Coordinator of Journal of Neuroscience and Neurological Surgery, "The peer review process was very quick and of high quality, which can also be seen in the articles in the journal. The collaboration with the editorial office was very good."

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Thomas Urban

I would like to express my sincere gratitude for the support and efficiency provided by the editorial office throughout the publication process of my article, “Delayed Vulvar Metastases from Rectal Carcinoma: A Case Report.” I greatly appreciate the assistance and guidance I received from your team, which made the entire process smooth and efficient. The peer review process was thorough and constructive, contributing to the overall quality of the final article. I am very grateful for the high level of professionalism and commitment shown by the editorial staff, and I look forward to maintaining a long-term collaboration with the International Journal of Clinical Case Reports and Reviews.

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Cristina Berriozabal

To Dear Erin Aust, I would like to express my heartfelt appreciation for the opportunity to have my work published in this esteemed journal. The entire publication process was smooth and well-organized, and I am extremely satisfied with the final result. The Editorial Team demonstrated the utmost professionalism, providing prompt and insightful feedback throughout the review process. Their clear communication and constructive suggestions were invaluable in enhancing my manuscript, and their meticulous attention to detail and dedication to quality are truly commendable. Additionally, the support from the Editorial Office was exceptional. From the initial submission to the final publication, I was guided through every step of the process with great care and professionalism. The team's responsiveness and assistance made the entire experience both easy and stress-free. I am also deeply impressed by the quality and reputation of the journal. It is an honor to have my research featured in such a respected publication, and I am confident that it will make a meaningful contribution to the field.

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Dr Tewodros Kassahun Tarekegn

"I am grateful for the opportunity of contributing to [International Journal of Clinical Case Reports and Reviews] and for the rigorous review process that enhances the quality of research published in your esteemed journal. I sincerely appreciate the time and effort of your team who have dedicatedly helped me in improvising changes and modifying my manuscript. The insightful comments and constructive feedback provided have been invaluable in refining and strengthening my work".

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Dr Shweta Tiwari

I thank the ‘Journal of Clinical Research and Reports’ for accepting this article for publication. This is a rigorously peer reviewed journal which is on all major global scientific data bases. I note the review process was prompt, thorough and professionally critical. It gave us an insight into a number of important scientific/statistical issues. The review prompted us to review the relevant literature again and look at the limitations of the study. The peer reviewers were open, clear in the instructions and the editorial team was very prompt in their communication. This journal certainly publishes quality research articles. I would recommend the journal for any future publications.

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Dr Farooq Wandroo

Dear Jessica Magne, with gratitude for the joint work. Fast process of receiving and processing the submitted scientific materials in “Clinical Cardiology and Cardiovascular Interventions”. High level of competence of the editors with clear and correct recommendations and ideas for enriching the article.

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Dr Anyuta Ivanova

We found the peer review process quick and positive in its input. The support from the editorial officer has been very agile, always with the intention of improving the article and taking into account our subsequent corrections.

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Dr David Vinyes

My article, titled 'No Way Out of the Smartphone Epidemic Without Considering the Insights of Brain Research,' has been republished in the International Journal of Clinical Case Reports and Reviews. The review process was seamless and professional, with the editors being both friendly and supportive. I am deeply grateful for their efforts.

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Gertraud Teuchert-Noodt

To Dear Erin Aust – Editorial Coordinator of Journal of General Medicine and Clinical Practice! I declare that I am absolutely satisfied with your work carried out with great competence in following the manuscript during the various stages from its receipt, during the revision process to the final acceptance for publication. Thank Prof. Elvira Farina

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Dr Elvira Farina

Dear Jessica, and the super professional team of the ‘Clinical Cardiology and Cardiovascular Interventions’ I am sincerely grateful to the coordinated work of the journal team for the no problem with the submission of my manuscript: “Cardiometabolic Disorders in A Pregnant Woman with Severe Preeclampsia on the Background of Morbid Obesity (Case Report).” The review process by 5 experts was fast, and the comments were professional, which made it more specific and academic, and the process of publication and presentation of the article was excellent. I recommend that my colleagues publish articles in this journal, and I am interested in further scientific cooperation. Sincerely and best wishes, Dr. Oleg Golyanovskiy.

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Dr Oleg Golyanovski

Dear Ashley Rosa, Editorial Coordinator of the journal - Psychology and Mental Health Care. " The process of obtaining publication of my article in the Psychology and Mental Health Journal was positive in all areas. The peer review process resulted in a number of valuable comments, the editorial process was collaborative and timely, and the quality of this journal has been quickly noticed, resulting in alternative journals contacting me to publish with them." Warm regards, Susan Anne Smith, PhD. Australian Breastfeeding Association.

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Dr Susan Anne Smith

Dear Jessica Magne, Editorial Coordinator, Clinical Cardiology and Cardiovascular Interventions, Auctores Publishing LLC. I appreciate the journal (JCCI) editorial office support, the entire team leads were always ready to help, not only on technical front but also on thorough process. Also, I should thank dear reviewers’ attention to detail and creative approach to teach me and bring new insights by their comments. Surely, more discussions and introduction of other hemodynamic devices would provide better prevention and management of shock states. Your efforts and dedication in presenting educational materials in this journal are commendable. Best wishes from, Farahnaz Fallahian.

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Dr Farahnaz Fallahian

Dear Maria Emerson, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews, Auctores Publishing LLC. I am delighted to have published our manuscript, "Acute Colonic Pseudo-Obstruction (ACPO): A rare but serious complication following caesarean section." I want to thank the editorial team, especially Maria Emerson, for their prompt review of the manuscript, quick responses to queries, and overall support. Yours sincerely Dr. Victor Olagundoye.

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Dr Victor Olagundoye

Dear Ashley Rosa, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews. Many thanks for publishing this manuscript after I lost confidence the editors were most helpful, more than other journals Best wishes from, Susan Anne Smith, PhD. Australian Breastfeeding Association.

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Dr Susan Anne Smith

Dear Agrippa Hilda, Editorial Coordinator, Journal of Neuroscience and Neurological Surgery. The entire process including article submission, review, revision, and publication was extremely easy. The journal editor was prompt and helpful, and the reviewers contributed to the quality of the paper. Thank you so much! Eric Nussbaum, MD

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Dr Eric S Nussbaum

Dr Hala Al Shaikh This is to acknowledge that the peer review process for the article ’ A Novel Gnrh1 Gene Mutation in Four Omani Male Siblings, Presentation and Management ’ sent to the International Journal of Clinical Case Reports and Reviews was quick and smooth. The editorial office was prompt with easy communication.

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Hala Al Shaikh

Dear Erin Aust, Editorial Coordinator, Journal of General Medicine and Clinical Practice. We are pleased to share our experience with the “Journal of General Medicine and Clinical Practice”, following the successful publication of our article. The peer review process was thorough and constructive, helping to improve the clarity and quality of the manuscript. We are especially thankful to Ms. Erin Aust, the Editorial Coordinator, for her prompt communication and continuous support throughout the process. Her professionalism ensured a smooth and efficient publication experience. The journal upholds high editorial standards, and we highly recommend it to fellow researchers seeking a credible platform for their work. Best wishes By, Dr. Rakhi Mishra.

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Dr Rakhi Mishra

Dear Jessica Magne, Editorial Coordinator, Clinical Cardiology and Cardiovascular Interventions, Auctores Publishing LLC. The peer review process of the journal of Clinical Cardiology and Cardiovascular Interventions was excellent and fast, as was the support of the editorial office and the quality of the journal. Kind regards Walter F. Riesen Prof. Dr. Dr. h.c. Walter F. Riesen.

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Dr Walter F Riesen

Dear Ashley Rosa, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews, Auctores Publishing LLC. Thank you for publishing our article, Exploring Clozapine's Efficacy in Managing Aggression: A Multiple Single-Case Study in Forensic Psychiatry in the international journal of clinical case reports and reviews. We found the peer review process very professional and efficient. The comments were constructive, and the whole process was efficient. On behalf of the co-authors, I would like to thank you for publishing this article. With regards, Dr. Jelle R. Lettinga.

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Dr Jelle Lettinga

Dear Clarissa Eric, Editorial Coordinator, Journal of Clinical Case Reports and Studies, I would like to express my deep admiration for the exceptional professionalism demonstrated by your journal. I am thoroughly impressed by the speed of the editorial process, the substantive and insightful reviews, and the meticulous preparation of the manuscript for publication. Additionally, I greatly appreciate the courteous and immediate responses from your editorial office to all my inquiries. Best Regards, Dariusz Ziora

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Dariusz Ziora

Dear Chrystine Mejia, Editorial Coordinator, Journal of Neurodegeneration and Neurorehabilitation, Auctores Publishing LLC, We would like to thank the editorial team for the smooth and high-quality communication leading up to the publication of our article in the Journal of Neurodegeneration and Neurorehabilitation. The reviewers have extensive knowledge in the field, and their relevant questions helped to add value to our publication. Kind regards, Dr. Ravi Shrivastava.

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Dr Ravi Shrivastava

Dear Clarissa Eric, Editorial Coordinator, Journal of Clinical Case Reports and Studies, Auctores Publishing LLC, USA Office: +1-(302)-520-2644. I would like to express my sincere appreciation for the efficient and professional handling of my case report by the ‘Journal of Clinical Case Reports and Studies’. The peer review process was not only fast but also highly constructive—the reviewers’ comments were clear, relevant, and greatly helped me improve the quality and clarity of my manuscript. I also received excellent support from the editorial office throughout the process. Communication was smooth and timely, and I felt well guided at every stage, from submission to publication. The overall quality and rigor of the journal are truly commendable. I am pleased to have published my work with Journal of Clinical Case Reports and Studies, and I look forward to future opportunities for collaboration. Sincerely, Aline Tollet, UCLouvain.

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Dr Aline Tollet

Dear Ms. Mayra Duenas, Editorial Coordinator, International Journal of Clinical Case Reports and Reviews. “The International Journal of Clinical Case Reports and Reviews represented the “ideal house” to share with the research community a first experience with the use of the Simeox device for speech rehabilitation. High scientific reputation and attractive website communication were first determinants for the selection of this Journal, and the following submission process exceeded expectations: fast but highly professional peer review, great support by the editorial office, elegant graphic layout. Exactly what a dynamic research team - also composed by allied professionals - needs!" From, Chiara Beccaluva, PT - Italy.

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Dr Chiara Giuseppina Beccaluva

Dear Maria Emerson, Editorial Coordinator, we have deeply appreciated the professionalism demonstrated by the International Journal of Clinical Case Reports and Reviews. The reviewers have extensive knowledge of our field and have been very efficient and fast in supporting the process. I am really looking forward to further collaboration. Thanks. Best regards, Dr. Claudio Ligresti

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Dr Claudio Ligresti

Dear Chrystine Mejia, Editorial Coordinator, Journal of Neurodegeneration and Neurorehabilitation. “The peer review process was efficient and constructive, and the editorial office provided excellent communication and support throughout. The journal ensures scientific rigor and high editorial standards, while also offering a smooth and timely publication process. We sincerely appreciate the work of the editorial team in facilitating the dissemination of innovative approaches such as the Bonori Method.” Best regards, Dr. Matteo Bonori.

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Dr Matteo Bonori

I recommend without hesitation submitting relevant papers on medical decision making to the International Journal of Clinical Case Reports and Reviews. I am very grateful to the editorial staff. Maria Emerson was a pleasure to communicate with. The time from submission to publication was an extremely short 3 weeks. The editorial staff submitted the paper to three reviewers. Two of the reviewers commented positively on the value of publishing the paper. The editorial staff quickly recognized the third reviewer’s comments as an unjust attempt to reject the paper. I revised the paper as recommended by the first two reviewers.

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Edouard Kujawski

Dear Maria Emerson, Editorial Coordinator, Journal of Clinical Research and Reports. Thank you for publishing our case report: "Clinical Case of Effective Fetal Stem Cells Treatment in a Patient with Autism Spectrum Disorder" within the "Journal of Clinical Research and Reports" being submitted by the team of EmCell doctors from Kyiv, Ukraine. We much appreciate a professional and transparent peer-review process from Auctores. All research Doctors are so grateful to your Editorial Office and Auctores Publishing support! I amiably wish our article publication maintained a top quality of your International Scientific Journal. My best wishes for a prosperity of the Journal of Clinical Research and Reports. Hope our scientific relationship and cooperation will remain long lasting. Thank you very much indeed. Kind regards, Dr. Andriy Sinelnyk Cell Therapy Center EmCell

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Dr Andriy Sinelnyk

Dear Editorial Team, Clinical Cardiology and Cardiovascular Interventions. It was truly a rewarding experience to work with the journal “Clinical Cardiology and Cardiovascular Interventions”. The peer review process was insightful and encouraging, helping us refine our work to a higher standard. The editorial office offered exceptional support with prompt and thoughtful communication. I highly value the journal’s role in promoting scientific advancement and am honored to be part of it. Best regards, Meng-Jou Lee, MD, Department of Anesthesiology, National Taiwan University Hospital.

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Dr Meng-JouLe

Dear Editorial Team, Journal-Clinical Cardiology and Cardiovascular Interventions, “Publishing my article with Clinical Cardiology and Cardiovascular Interventions has been a highly positive experience. The peer-review process was rigorous yet supportive, offering valuable feedback that strengthened my work. The editorial team demonstrated exceptional professionalism, prompt communication, and a genuine commitment to maintaining the highest scientific standards. I am very pleased with the publication quality and proud to be associated with such a reputable journal.” Warm regards, Dr. Mahmoud Kamal Moustafa Ahmed

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Mahmoud Kamal Moustafa Ahmed

Dear Maria Emerson, Editorial Coordinator of ‘International Journal of Clinical Case Reports and Reviews’, I appreciate the opportunity to publish my article with your journal. The editorial office provided clear communication during the submission and review process, and I found the overall experience professional and constructive. Best regards, Elena Salvatore.

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Dr Elena Salvatore

Dear Mayra Duenas, Editorial Coordinator of ‘International Journal of Clinical Case Reports and Reviews Herewith I confirm an optimal peer review process and a great support of the editorial office of the present journal

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Christoph Maurer

Dear Editorial Team, Clinical Cardiology and Cardiovascular Interventions. I am really grateful for the peers review; their feedback gave me the opportunity to reflect on the message and impact of my work and to ameliorate the article. The editors did a great job in addition by encouraging me to continue with the process of publishing.

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Baciulescu Laura

Dear Cecilia Lilly, Editorial Coordinator, Endocrinology and Disorders, Thank you so much for your quick response regarding reviewing and all process till publishing our manuscript entitled: Prevalence of Pre-Diabetes and its Associated Risk Factors Among Nile College Students, Sudan. Best regards, Dr Mamoun Magzoub.

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Dr Mamoun Magzoub