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Local reactions such as induration, swelling and reddening have been reported more often than systemic reactions. In a comparative trial in normal volunteers, Dreesen et al. (3, 24) described their experience with RabAvert (rabies vaccine) compared to a HDCV rabies vaccine. Nineteen subjects received RabAvert (rabies vaccine) and 20 received HDCV. The most commonly reported adverse reaction was pain at the injection site, reported in 45% of the HDCV group, and 34% of the RabAvert (rabies vaccine) group. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15 % RabAvert (rabies vaccine) group vs. 25 % HDCV group), headache (10 % RabAvert (rabies vaccine) group vs. 20 % HDCV group), and dizziness (15 % RabAvert (rabies vaccine) group vs. 10 % HDCV group). In a recent study in the USA (4), 83 subjects received RabAvert (rabies vaccine) and 82 received HDCV. Again, the most common adverse reaction was pain at the injection site in 80% in the HDCV group and 84% in the RabAvert (rabies vaccine) group. The most common systemic reactions were headache (52% RabAvert (rabies vaccine) group vs. 45% HDCV group), myalgia (53% RabAvert (rabies vaccine) group vs. 38% HDCV group) and malaise (20% RabAvert (rabies vaccine) group vs. 17% HDCV group). None of the adverse events was serious, almost all adverse events were of mild or moderate intensity. Statistically significant differences between vaccination groups were not found. Both vaccines were generally well tolerated.
Uncommonly observed adverse events include temperatures above 38°C (100°F), swollen lymph nodes, and gastrointestinal complaints. In rare cases, patients have experienced severe headache, fatigue, circulatory reactions, sweating, chills, monoarthritis and allergic reactions; transient paresthesias and one case of suspected urticaria pigmentosa have also been reported.
Type III hypersensitivity reactions in pre-exposure booster immunizations have been reported with one HDCV rabies vaccine (25 - 27). These reactions are thought to be due to small amounts of human serum albumin (HSA) rendered allergenic by beta-propiolactone (23, 28, 29). Human serum albumin (HSA) is present in RabAvert (rabies vaccine) at concentrations less than 0.3 μg/dose. No type III hypersensitivity reactions have been observed with RabAvert (rabies vaccine) (30).
Serious systemic anaphylactic reactions or neuroparalytic events have been reported in association with RabAvert (rabies vaccine) administration. Against a background of 11.8 million doses distributed world-wide 10 cases of encephalitis (1 death) or meningitis, 7 cases of transient paralysis including 2 cases of Guillain-Barré Syndrome, 1 case of myelitis, 1 case of retrobulbar neuritis, and 2 cases of suspected multiple sclerosis have been temporally associated with the use of RabAvert (rabies vaccine) . Also, 2 cases of anaphylactic shock have been reported. A patient's risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization (see WARNINGS).
The use of corticosteroids to treat life-threatening neuroparalytic reactions may inhibit the development of immunity to rabies (see PRECAUTIONS: DRUG INTERACTIONS).
Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory and antipyretic agents.
Reporting of Adverse Events
Adverse events should be reported by the health care provider or patient to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Report forms and information about reporting requirements or completion of the form can be obtained from VAERS by calling the toll-free number 1-800-822-7967 (26). In the USA, such events can be reported to the Professional Services Department, Chiron Corporation: phone: 1-888-CHIRON-7.
Read the Rabavert (rabies vaccine) Side Effects Center for a complete guide to possible side effects
Corticosteroids, other immunosuppressive agents, antimalarials and immunosuppressive illnesses can interfere with the development of active immunity after vaccination, and may diminish the protective efficacy of the vaccine. Pre-exposure prophylaxis should be administered to such persons with the awareness that the immune response may be inadequate. Immunosuppressive agents should not be administered during post-exposure therapy unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, it is important that a serum sample be tested for rabies antibody to ensure that an acceptable antibody response has been induced (23).
Rabies Immuno Globulin must not be administered at more than the recommended dose, since response to active immunization may be impaired.
Use in Pregnancy
Category C. Animal reproductive studies have not been conducted with RabAvert (rabies vaccine) . It is also not known whether RabAvert (rabies vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RabAvert (rabies vaccine) should be given to a pregnant woman only if clearly needed. However, because of the potential consequences of inadequately treated rabies exposure, and limited data which indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to post-exposure prophylaxis. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy. However, in such instances, consideration should be given to removing the pregnant woman from the high risk environment.
3. Dreesen DW, et al. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for pre-exposure immunization. Vaccine. 1989; 7: 397-400.
4. Dreesen DW. Investigation of antibody response to purified chick embryo cell tissue culture vaccine (PCECV) or human diploid cell culture vaccine (HDCV) in healthy volunteers. Study synopsis 7USA401RA, September 1996 - December 1996 (unpublished).
17. Sehgal S, et al. Ten year longitudinal study of efficacy and safety of purified chick embryo cell vaccine for pre- and post-exposure prophylaxis of rabies in Indian population. J Commun Dis. 1995; 27: 36-43.
23. Centers for Disease Control. Rabies Prevention - United States, 1991. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1991; 40 (RR-3): 1-19.
24. Dreesen D. et al.: A comparative study of cell culture rabies vaccine: Immunogenicity and safety. Protocol 8USA301RA, 1985 -1986 (unpublished).
25. Centers for Disease Control. Systemic allergic reactions following immunization with HDC rabies vaccine. MMWR. 1984; 33: 185-187.
26. Centers for Disease Control. Rabies Prevention - United States. MMWR. 1984; 33: 393-402.
27. Dreesen DW, et al. Immune complex-like disease in 23 persons following a booster dose of rabies HDC vaccine. Vaccine. 1986; 4: 45-49.
28. Anderson, MC, et al. The role of specific IgE and beta-propiolactone in reactions resulting from booster dose of human diploid rabies cell vaccine. J Allergy Clin. Immunol. 1987; 80: 861-868.
29. Swanson MC, et al. IgE and IgG antibodies to beta-propiolactone and human serum albumin associated with urticarial reactions to rabies vaccine. J Infect Dis. 1987; 155: 909-913.
30. Marwick C. Changes recommended in use of human diploid cell rabies vaccine (news). JAMA. 1985; 245: 14-15.
31. Lumbiganon P, Wasi C. Survival after rabies immunisation in newborn infant of affected mother. Lancet. 1990; 336: 319-332.
32. Lumbiganon P, et al. Pre-exposure vaccination with purified chick embryo cell rabies vaccines in children. Asian Pacific J Allergy Immunol, 1989; 7: 99-101.
33. Gonzales de Ciso. Comparative evaluation of PCEC and Fluenzalida vaccines. Protocol 8Mex201RA, 1983 - 1984 (unpublished).
Last reviewed on RxList: 2/23/2009
This monograph has been modified to include the generic and brand name in many instances.
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