local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. c axillary swelling or tenderness was collected as a solicited local adverse reaction (i.e., lymphadenopathy: localized axillary swelling or tenderness ipsilateral to the vaccination arm); grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization. lymphadenopathy: localized axillary swelling or tenderness ipsilateral to the vaccination arm); grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization.
grade 4 fever (>40.0°c) was reported by four vaccine recipients after dose 1 and 11 vaccine recipients after dose 2. there was one report of grade 4 fatigue and one report of grade 4 arthralgia, both in the younger age group after dose 1. in the older age group, there was one report of grade 4 nausea or vomiting after dose 2. no other systemic grade 4 reactions were reported. a higher frequency of unsolicited adverse events was reported in the vaccine group compared to the placebo group and was primarily attributed to local and systemic reactogenicity following vaccination. one case of bell’s palsy in the vaccine group was considered a serious adverse event. the proportions of participants who reported at least one serious adverse event were 1% in the vaccine group and 1% in the placebo group.
improving our understanding of vaccine safety is important to reduce the occurrence of vaccine aes and maintain public confidence in vaccines. the continuous monitoring of vaccine safety in the general population after licensure (known as postlicensure or postmarketing surveillance) is needed to identify and evaluate risk for such aes after vaccination. persons who are not healthcare providers are encouraged to consult with a healthcare provider to ensure that information is complete and accurate and that their provider is aware of the ae. reporting to vaers online (i.e., web-based reporting) is strongly encouraged since it allows for quicker receipt and processing of the information. this is done by means of a quarterly e-mail request from vaers to the state health department.
this reference may be useful to providers or public health officials who are called on to answer the public’s questions on vaccine safety and the occurrence of aes. data on the number of doses of influenza vaccine distributed are calculated by cdc and made available to the public but are not product specific by brand or manufacturer. reports to vaers may not be representative of all aes that occur. the vaers staff routinely contacts reporters — health care providers and parents or vaccine recipients — to obtain missing information or to correct inaccurate information for all reports of deaths, serious aes, and other selected clinically significant events. reporting an event to vaers does not result in the filing of a claim to the vicp. the cisa network’s goals are to study mechanisms of vaccine aes, study individual risk factors for aes, serve as a resource to provide consultation for difficult vaccine safety issues, and to assist in developing vaccine safety guidance.
rare instances of adverse events following covid-19 vaccinations have been reported to the vaccine adverse event reporting system. local reactions occur where the shot was given. they are usually mild and occur within a few hours of the shot. systemic reactions include fever, headache, vaers is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. vaers, .
the vaccine adverse event reporting system (vaers) is an early warning system that helps cdc and the food and drug administration (fda) monitor health vaers collects reports of possible adverse events that happen after vaccination. anyone can submit a report to vaersexternal icon, including patients, parents the vaccine adverse event reporting system (vaers) database contains information on unverified reports of adverse events (illnesses, health problems and/or, .
When you try to get related information on cdc adverse events, you may look for related areas. .