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Respiratory Diseases
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Aref T. Senno, Ryan K. Brannon
Women planning to conceive, pregnant—in any trimester—and postpartum even while breastfeeding should be actively encouraged and recommended to get vaccinated for COVID-19 infection. At the time of publication, several dozen COVID-19 vaccines are currently in varying stages of development. While vaccine development usually takes years, several vaccines were approved for use globally within the first year of COVID-19. The long-term impact regarding side effects, adverse events, and immunity will likely be largely unknown, in part due to this expedited process. Most pregnancy safety data available as of this writing come from the messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. mRNA is quickly metabolized in human cells after stimulating antibody production. As a result, mRNA never enters the nucleus and therefore does not change maternal or fetal genetic material. Moreover, greater than 30,000 pregnancies have been self-reported to the CDC's V-safe After Vaccination Health Checker as of this writing. This registry has data on 275 completed pregnancies [152]. The CDC's Vaccine Adverse Event Reporting System (VAERS) has data on 154 pregnancies. No excess in side effects or adverse events has been observed compared with the CDC national birth data.
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.
Human Papillomavirus Genital Infections
Published in William J. Ledger, Steven S. Witkin, Vulvovaginal Infections, 2017
William J. Ledger, Steven S. Witkin
There is a note of great reassurance about the use of any of the HPV vaccines: they are safe. Ongoing postlicensure surveillance indicated as of March 2014 that about 67 million vaccine doses had been administered in the United States with only 25,176 adverse events reported to the Vaccine Adverse Event Reporting System, 92% of which were “not serious.”44 The serious events included headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness. Of great clinical interest, the U.S. Centers for Disease Control and Prevention has reported that adverse event reports peaked within 2 years of the first use of the vaccine and decreased dramatically in each of the subsequent 5 years.45 It is abundantly clear that physicians have a highly effective and safe vaccine available to them.
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).
Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention
Published in Expert Review of Vaccines, 2019
Pedro L. Moro, Penina Haber, Michael M. McNeil
Following licensing, CDC’s Advisory Committee on Immunization Practices (ACIP) makes specific recommendations whether to incorporate the vaccine into the age appropriate routine immunization schedule after an in-depth review of vaccine-related data, including data on disease epidemiology, vaccine efficacy and effectiveness, vaccine safety, feasibility of program implementation, and economic aspects of immunization policy. Following licensure by FDA, and often along with recommendations by ACIP, CDC, and the FDA continuously monitor vaccines for safety. Post licensure evaluation of vaccine safety is critical because rare reactions, delayed reactions, or reactions among special populations may not be detected before vaccines are licensed. Several monitoring systems are used in the United States to detect and study AEs that occur after immunizations. In addition to phase 4 studies required of manufacturers, the CDC and FDA use two main systems to monitor the safety of vaccines in use: the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) (Table 1).
An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine
Published in Expert Review of Vaccines, 2018
Pavitra Keshavan, Michele Pellegrini, Kumaran Vadivelu-Pechai, Michael Nissen
Finally, a US study investigated all adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from 1 January 2010 until 31 December 2015 [60]. During this period approximately 8.2 million doses of MenACWY-CRM were distributed in the US. Of the 2614 AE reports received over the study period, 74% were in 11–18 year olds and 53% included concomitant administration of MenACWY-CRM with other vaccine(s). Overall, across the different age groups, the most frequently reported AEs were injection site reactions. There were no unexpected findings and no disproportionate reporting of any AEs, including facial palsy. The reported AEs were consistent with data from pre-licensure studies as reflected in the Product Information.