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Influenza neurologic complications
Published in Avindra Nath, Joseph R. Berger, Clinical Neurovirology, 2020
Larry E. Davis, Jennifer R. Plourde
Since 1978, influenza vaccine program, active surveillance for GBS following vaccination has occurred. In addition, a US Vaccine Adverse Event Reporting System (VAERS) supported by the CDC was established [96]. VAERS is a voluntary reporting system for adverse events to all vaccines. VAERS and a similar UK reporting system have reported either no increased risk or a minimal increased risk of fewer than one to two GBS cases per million persons vaccinated associated with previous influenza vaccines and for recent influenza vaccines [97]. Currently, the CDC also conducts active GBS surveillance in 10 states in its Emerging Infections Program. All these prospective studies find an excess risk of 0.8 cases per one million vaccinations. Thus, no satisfactory explanation why the 1976 swine influenza vaccine caused a much higher rate of associated GBS cases following vaccination compared to all subsequent influenza vaccine strains has been found.
Prevention
Published in William Bonnez, Guide to Genital HPV Diseases and Prevention, 2019
William Bonnez, Darron R. Brown, Cynthia M. Rand
Some of the information available comes from the Vaccine Adverse Event Reporting System (VAERS) managed by the U.S. FDA and CDC. Anybody, not necessarily a physician or a patient can report to VAERS. Dizziness (13%), syncope (10%), injection site pain (19%), nausea (9%), pain (7%), and rash (7%) were among the seven most frequently reported symptoms. Syncope with sometimes a fall resulting in injury led the ACIP to recommend the observation of the patient for 15 minutes after administration of the vaccine.
How Drugs Are Discovered, Tested, and Approved
Published in William N. Kelly, Pharmacy, 2018
To help monitor the serious adverse effects of drugs, the FDA has a reporting system called MedWatch. Serious ADRs are fatal, are life threatening, cause hospitalization, prolong hospitalization, or result in disability. ADRs are reported to the FDA by health-care personnel or patients through MedWatch. The FDA quickly puts all reports into a computer system and then searches for any significant patterns. There is a similar program for the reporting of serious ADRs for vaccines. This program is cosponsored by the FDA and the Centers for Disease Control and Prevention (CDC) and is called the Vaccine Adverse Event Reporting System (VAERS).
Safety outcomes associated with the moderna COVID-19 vaccine (mRNA-1273): a literature review
Published in Expert Review of Vaccines, 2023
Angel Shabu, Prasad S. Nishtala
On-going safety research for the mRNA-1273 vaccine is essential since it is relatively new and long-term safety data is limited. The continued large-scale epidemiological study will allow monitoring of the known AEs, identification of emerging/rare AEs, detection of variations in AEs experienced among different populations and identification of potential risk factors for specific AEs. Additionally, large-scale epidemiological studies with longer follow-up periods are required to surveillance rare safety outcomes of this vaccine. Utilization and awareness of spontaneous reporting systems such as VAERs should be encouraged for the continued capture and surveillance of adverse events following vaccination. The accessibility of such platforms enables early detection of rare AEs, which many RCTs are not powered to detect. However, a major limitation of spontaneous reporting systems is the absence of a control group. Therefore, large-scale observational studies, such as registry-based studies, are warranted to determine a causal relationship between the mRNA-1273 vaccine and the AE of interest. This will allow the public and healthcare professionals to make informed and patient-centered decisions regarding vaccine uptake.
Herpes zoster and simplex reactivation following COVID-19 vaccination: new insights from a vaccine adverse event reporting system (VAERS) database analysis
Published in Expert Review of Vaccines, 2022
Michele Gringeri, Vera Battini, Gianluca Cammarata, Giulia Mosini, Greta Guarnieri, Chiara Leoni, Marco Pozzi, Sonia Radice, Emilio Clementi, Carla Carnovale
VAERS is an early warning system co-managed by the Centers for Disease Control and Prevention (CDC) and the FDA and has a key role in detecting potential safety issues concerning FDA-approved vaccines. Since 1990, over 1,225,000 records have been filed by healthcare professionals and manufacturers, who are required to report any suspected AE that occurs following vaccination, and also consumers. Each AE report is filed in the VAERS in the form of Individual Case Safety Report (ICSR), which provides the whole case narrative, accessible on the public version of the VAERS and comprehensive of administrative (e.g. Country and State of occurrence, qualification of the reporter) and demographic (e.g. patient sex, age, weight, previous AEs, chronic conditions) characteristics, AE (e.g. symptoms, seriousness, outcome, medical tests and laboratory results) and suspect vaccine (e.g. name, administration date, time to onset, route) details, along with information concerning any potential drug or vaccine administered at the time of AE but not held responsible for its occurrence by the reporter, referred to as ‘concomitant medication.’ VAERS also performs a process of selection of higher quality cases, since it may request additional information from reporters and, whether multiple reports of a single AE are received, only the most updated version is included in the publicly accessible dataset.
The Development of Human Papillomavirus (HPV) Vaccines and Current Barriers to Implementation
Published in Immunological Investigations, 2021
Rebecca Butterfield, Salimah Dhanani
HPV vaccines have been extensively studied for adverse effects. The safety data collected in the phase 3 trials show that despite high immunogenicity, HPV vaccines are well tolerated in men and women. There were approximately 56 million doses of 4vHPV distributed in the United States from 2006 to 2013. During that period, the Vaccine Adverse Event Reporting System (VAERS) reported 21,194 adverse events after vaccination, with 92% classified as non-serious. Serious reactions included life-threatening reactions or those resulting in hospitalization or disability. None of the reported serious reactions could be directly attributed to HPV vaccination. The rate of adverse events through VAERS was consistent with pre-licensure clinical trial data. Adverse reports peaked in number in 2008 and have decreased annually since and have not changed from the prior pre and post-licensure safety data (MMWR 2013; Neha et al. 2020). The most frequently reported non-serious adverse events to include syncope, headache, dizziness, fever, nausea, urticaria, and localized swelling, redness, or pain. Local pain and swelling at the injection site occurred in 20–90% of individuals after the HPV vaccine. Syncope has been reported among adolescents who receive the vaccination, so it is recommended that adolescents be given the vaccine sitting or lying down and be observed for 15 minutes post-vaccination (CDC 2015).