Vaccines adverse reaction events from

Important Note Statistical information about smallpox vaccine adverse reactions is ba.sed on data from two studies conducted in 1968. Adverse event rates in the United States today may be higher because there may be more people at risk from immune suppression (from cancer, cancer therapy, organ transplants, and illnesses such as HIV/AIDS) and eczema or atopic dermatitis. The outcome a.ssociated with adverse events may be less severe than previously reported because of advances in medical care. Rates may be lower for persons previously vaccinated. 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

Experience with PRP-D derives from Finland and Iceland. In Finland, 14.1 adverse reactions per 100 000 doses were reported in aU, consisting respectively of 5.3, 6.3, 4.4, and 2.9 per 100 000 doses of local reactions, fever, rash, and irritability. These rates probably underestimate the true rate. In Iceland, adverse effects have not been monitored, but no serious events have been reported. For PRP-CRM, there were 17.8 per 100 000 doses in aU, of which 7.7 per 100 000 doses were due to local reactions, 8.9 to fever, and 8.3 to rash. PRP-T currently enjoys the largest use in Scandinavia, being the routine choice in three countries. Of 115 reactions reported in Denmark, none was of serious concern most were local reactions, fever, or rash. In Norway, the incidence of systemic reactions was 1 in 550 doses fever and other symptoms and signs similar to those after DTP vaccination were the most common complaints. However, two findings were characteristic of Norway, where local reactions were reported with an overall frequency of 1/1500 doses ... 

By 1988 it was possible to summarize the adverse effects reported after the distribution of over 1.8 million doses of plasma-derived hepatitis B vaccine (Table 1) (2). From 1982 onwards, the Centers for Disease Control, the Food and Drug Administration, and the manufacturers, Merck Sharp Dohme, had supported a special surveillance system to monitor spontaneous reports of reactions to plasma-derived hepatitis vaccine. During the first 3 years, about 850 000 persons were immunized. In all, 41 reports were received for one of the following neurological adverse events convulsion (n = 5), Bell s palsy (n — 10), Guillain-Barre syndrome (n = 9), lumbar radiculopathy (n — 5), brachial plexus neuropathy (n = 3), optic neuritis (n — 5), and transverse myelitis (n = 4). Half of these events occurred after the first vaccine dose. However, no conclusive causal association could be made between any neurological adverse event and the vaccine (3). 

Hypersensitivity reactions (generalized urticaria or angio-edema) after the use of Japanese encephahtis vaccine have been reported from some countries (see Table 1) the vaccine constituents responsible for these events have not been identified (12). There has been a detailed report of the adverse effects, mainly allergic mucocutaneous reactions, of Biken vaccine in Danish travellers and US Marine Corps personnel (SEDA-22, 351). 

LYMErix safety data reported to the Vaccine Adverse Event Reporting System (VAERS) from 21 December 1998 to 31 October 2000 mentioned reports of adverse events associated with Lyme vaccine in prelicensure trials, including injection site reactions, transient arthralgia and myalgia within 30 days of vaccination, fever, and a flu-like illness (7). Allergic reactions were reported to the VAERS and some could have plausibly been linked to the vaccine because of the short latency between vaccination and reaction onset. No clear patterns in age, sex, time to onset, or vaccine dose were identified, although the unexpected predominance of reports of arthrosis in men might warrant further consideration. 

Geier DA, Geier MR. Rubella vaccine and arthritic adverse reactions an analysis of the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1998. Clin Exp Rheumatol 2001 19(6) 724-6. 

Report all clinically significant post-vaccination reactions to the Vaccine Adverse Event Reporting System (VAERS). Reporting forms and instructions on filing a VAERS report are available by calling 800-822-7967 or from the VAERS website at... 

Venous blood samples are collected from clinical subjects after approval by the regulatory authorities for the evaluation of medicines and the local ethical committees for the sampling and the experiments to be performed. The identities of the clinical subjects are blinded. The collection should contain samples of healthy infants or children of both genders and minorities, with at least five clinical subjects per group. If adverse event reactions are to be studied, the collection should also contain at each time-point of the study one group of clinical subjects who were reported to experience adverse events after vaccination. The clinical subjects are vaccinated intramuscularly with one dose of the vaccine at 3, 5, and 12mo of age. Samples are collected at 3 mo before the first vaccination and at 6 and 13 mo, with the second samples taken after their second vaccination at 5 mo of age and the third vaccination at 12mo of age, respectively. 

Postmarketing surveillance data of adverse events after Japanese encephalitis immunization in Japan and the USA have been compared (7). The rates of total reported adverse events were 2.8 per 100 000 doses in Japan and 15.0 per 100 000 doses in the USA. In Japan, 17 neurological disorders were reported from April 1996 to October 1998 (0.2 per 100 000 doses), whereas in the USA there were no serious neurological adverse events temporally associated with Japanese encephalitis vaccine from January 1993 to June 1999. Rates for systemic hypersensitivity reactions were 0.8 and 6.3 per 100 000 doses in Japan and the USA respectively. 

A critical examination (4) of a report (5) of several children whose chronic bowel and behavioral abnormalities were linked to measles, mumps, and rubella (MMR) immunization can be used as an example to underline Halsey s comments. Without effective and credible systems for the detection of vaccine-associated adverse events through pharmacovigilance, for distinguishing causal reactions from coincidental reactions by pharmacoepidemiological or other studies, and for risk communication, vaccine safety concerns may confuse the media and the public. 

Reported adverse events after immunization in New Zealand from 1990 to 1995 have been presented (24). Reactions at the injection site following adult tetanus + diphtheria vaccine were the most commonly reported (68 reports per 100 000 immunizations). The authors concluded that the picture confirmed the overall safety of vaccines and the value of an adverse events monitoring system. 

The withdrawal of tetravalent rhesus-based rotavirus vaccine from the market illustrates an important problem regarding prehcensure testing and its ability to identify rare vaccine-related adverse events. A sample size of 10 000 volunteers may provide excellent estimates of reactogenicity (local and systemic reactions) and efficacy but be inadequate as a denominator for ruling out rare adverse events. Table 3 shows how trial size determines the ability to detect frequent and rare events. Plans for future large prelicensure trials, for example for newly developed rotavirus vaccines, therefore include 10 000-60 000 volunteers. These large trials can be seen as a... 

Data from 20447 (+)MF59 and 7526 (—)MF59 vaccines were analysed. The (+) MF59 subjects had a higher risk of sohcited local or systemic reactions within 3 days of immunization (59% versus 47% weighted RR= 1.34 95% CI=1.28,1.40). The risks of any unsolicited adverse event were lower in the (+)MF59 subjects (27% versus 39% adjusted RR=0.65 95% CI=0.60, 0.70). The risks of other adverse events were... 

From Surveillance for Adverse Events Associated with Anthrax Vaccination—US Department of Defense, 1998-2000, Morbidity and Mortality Weekly Report 49, no. 16 (April 28, 2000), http //www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4916al.htm The findings indicate that rates of local reactions were higher in women than men and that no patterns of unexpected local or systemic adverse events have been identified. ... 

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