ADVERSE EFFECTS OF RABIES VACCINE

OBSERVED IN THE PEOPLE OF DIFFERENT AGE

GROUPS IN SUKRARAJ TROPICAL AND
INFECTIOUS DISEASES HOSPITAL

Krishna Neupane
Introduction
• Rabies is an acute viral zoonotic disease that causes fatal
encephalomyelitis in human and many other mammals.
• According to the World Health Organization (WHO); over 10 million
people per year, mostly from Asia are Vaccinated following contact
with the disease.
• Rabies vaccine is a vaccine used to prevent rabies.
• They used to prevent rabies before and for a period of time after
exposure to the virus such as by a dog or cat bite. The immunity that
develops is long lasting after a full course .
• Vaccination dogs is very effective in preventing the spread of rabies of
human.
• Primarily cell culture of embryonated egg based rabies vaccine are
also used worldwide .
Rabies vaccine used in Nepal
In Nepal the vaccine of Brand name Abhayrab is used for vaccination . It is manufactured
by Human Biological Institute ( A division of Indian immunological limited )
Composition:
Purified lyophilized Rabies Antigen derived from Rabies virus (L. Pasteur 2061/ Vero strain
propagated in Vero cells ) Inactivated .
• Potency : 2.5 I.U per vial
• Stabilizers: Maltose and and human albumin
• Preservative : Thiormesal 0.015% w/v
• Reconstitution: Reconstitute the freeze dried vaccine with 0.5ml diluent (0.9% Sodium
Choride Injection IP ) provided along with pack.
• Storage Temperature: It should be stored within 2 degree to 8 degree Celsius.
Working Mechanism of Rabies Vaccine

• Rabies vaccine contains inactivated rabies virus. It works by provoking

the body immune response to this virus , without actually causing the
disease. When body is exposed to foreign organism such as bacteria
and virus , the immune system produce antibody towards them.
These, antibodies kill such foreign organism . The rabies vaccine
stimulates against the rabies virus and is given to prevent the
diseases.
Route of vaccine administration

• Rabies vaccine is administered in skin and muscle . It is mainly given

by Intradermal and Intramuscular route. In most of the countries
rabies vaccine is given by Intramuscular route .
• In Nepal, it is given by Intradermal route.
Vaccination time and course of total
vaccination
• Day 0 is the day of first vaccination after bitten by animal within 24
hours.
• Day 3 is the second vaccination day
• Day 7 is the third vaccination day
• Day 14 is the fourth vaccination day
• Day 28 is the fifth vaccination day
Rational of the study
• Rabies continues to be an important public health problem in Nepal and many
other developing countries.
• Rabies vaccine is presumed to be cheap, although the actual cost of production
may not be low. However, it is not a safe vaccine as it causes demyelinating central
or peripheral nervous system side-effects in 1/3000–7000 persons vaccinated; this
adverse reaction is occasionally fatal.
• Cell culture rabies vaccines are also available in Nepal; unlike the Sample vaccine
they are safe and can be used for pre-exposure vaccination, but they are more
expensive.
• Thus, it is necessary to do more research regarding the clinician to evaluate a
patient’s response to treatment to determine the efficacy of the treatment and to
identify any adverse reaction.
• In this study, we investigated the side effects that developed in patients following
administration of anti rabies vaccine . We aimed to determine the differences in the
Objectives of the study
General Objectives
• To access of the adverse effect of ARV used in Nepal.

Specific Objectives
• To find out demographic pattern of patient vaccinated from ARV.
• To analyze the adverse effect of ARV in different age group.
• To find out medications used in ADR.
METHODOLOGY
Study area :
The study area was done in Sukraraj Tropical centre, Teku.
Study type:
The study type retrospective, cross sectional descriptive type.
Sample technique and sample size:
Simple random sampling of 176 patients were used.
 Patient Inclusion criteria:
• People above 5 years.
• People of different gender,
• People of different socioeconomic condition,
• People who are flexible and cooperating
Exclusion criteria:
• Children below 5 years,
• Patients on other medication,
• People who are not flexible and cooperating,
• Patient who is mentally disabled and incomplete clinical information.
Data collection technique and study duration
• A formal request was made from the concerned authority to the
hospital and verbal contest was done to obtain adverse reactions.
• The respondents were assured of confidentiality and privacy of the
information and encouraged to be sincere and truthful to the
responses.
• The data was collected through face to face interview with semi-
structure type of questionnaire
• A predesigned questionnaire was asked to patient and a written or
verbal consent will obtain from patient before starting interview as
well as laboratory reports .
DATA ANALYSIS AND ITS
INTERPRETATION
• All the collected data from Sukraraj Tropical and Infections diseases
hospital, teku from 22 August to 5th September, were entered in
Microsoft Excel 2010 version and analyzed by using IBM SPSS Statistics
version 25 software. Data were analyzed in terms of frequency,
distribution and percentage.
• Total number of the patients participated in this study were 176 in
which male patients were 53.4% and female patients were 46.6%.
• The patients among 176 interviewed victims 31 were from age group 5-
15,36 from age group 16-25, 36 from age group 26-35, 26 from age
group 36-45 , 22 from age group 46-55 and remaining 25 were patients
age ranged above 55.
• Majority of the patients treated with ARV came after the bitten by the
dog and minority of the patients came after the bitten by cat. No
other animal bitten cases are not included in this study.
Prevalence of ADRs due to ARV at STAIDH Teku, Kathmandu
(for all age groups)

70.00%

60.00%

50.00%

40.00%

30.00%

20.00%

10.00%

0.00%
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Adverse reaction in different age groups
• Age group (5-15):
Total number of participant were 31, in which 17 were male and 14 were
female patients. Adverse reaction in age group 5-15 must commonly
shows Redness (83.9%), Fever (80.6%) followed by Pain at site (71.0%).
Restlessness, vomiting and others reaction were not shown in this group.
• Age group (16-25):
Total number of participant were 36, in which 19 were male and 17 were
female patients Adverse reaction in age group 16-25 must commonly
shows Redness (52.8%) and Pain at site (52.8%) followed by Swelling
(47.2%).
• Age group (26-35):
Total number of participant were 36, in which 19 were male and 17 were
female patients Adverse reaction in age group 16-25 must commonly
shows Pain at site (52.8%), Muscle pain (52.8%) followed by Rednss(50%).
Fever adverse reaction was not shown in this group.
• Age group (36-45):
Total number of participant were 26, in which 14 were male and 12 were
female patients. Adverse reaction in age group 16-25 must commonly
shows Redness (50%), Itching (50.0%) followed by Pain at site (46.2%).
Dizziness, Nausea and fever adverse reaction were not shown in this
group.
• Age group (46-55):
Total number of participant were 22, in which 13 were male and 9 were
female patients. Adverse reaction in age group 16-25 must commonly
shows Redness (68.2%), Muscle pain (63.6%) followed by Pain, Swelling
and itching. Fever and others adverse reaction were not shown in this
group.
• Age group (55+):
Total number of participant were 25, in which 12 were male and 13were
female patients. Adverse reaction in age group 16-25 must commonly
shows Redness (60.0%) followed by Pain, Restlessness, Muscle pain and
fever.
Medications to mitigate adverse effects of
ARV
Adverse effect of ARV last for few days and
Drugs used Frequency Percentage of healed itself without further medication. But in
cases
some people, we found using of the medication
Lotion 3 2.83 %
for the ADR treatment. Only 39 people
Analgesic drug 11 11.22 % ( 22.15% ) out of 176 have taken medication

Anti-histamines 7 10.14 % for ADR. Out of the people showing fever as

ADR, 46.15% of them has taken Antipyretic
Anti-pyretic 18 46.15 %
medication. Similarly, 11.22% of people
showing Pain at site has taken analgesic
medication. Only 2.83% of the people whom
redness seen has taken lotion for the treatment.
Discussion
• Dog and other animal bites leading to risk of developing rabies will
continue to occur in most developing countries and there will be ever
increasing demand for safe and potent rabies vaccines. The rabies
virus is transmitted through exposure to saliva from an infected
animal bite, such as dogs, bats, skunks, raccoons, and cats. Rabies is
endemic in dogs in most South-East Asian countries and is most
commonly transmitted to humans via rabid dog bites. It can also be
transmitted from inhalation of aerosolized rabies virus, tissue and
organ transplants, or where broken skin or mucous membranes come
into contact with any infected body fluid, whether humans or
mammals.
• In our study, most frequently occurring side effect of Anti Rabies Vaccine is
Redness at site of injection (66.3%) followed by the Pain at site (61.3%), Itching
(53.8%),Muscle pain ( 45.6%) , Skin rash/ Allergy (43.1%), Weakness ( 32.5%)
and so on.
• Similar study carried out by Kimie J kagawa et al in 1992, most adverse reactions
were mild and limited to the injection site , as 63.5% of the students that
experienced adverse reactions reported pain and 48% redness at site. 40% ,
reported pruritus and 16% swelling at the injection site. Some students
reported nausea (6.3%), dizziness (3.2%), malaise (11%) and headache (14.3 %).
Fever (19.1%) and muscle aches (16%) were more frequently reported, and 4
subjects (6.3%) reported lymphadenopathy. Overall, local adverse reactions
occurred in no more than 12.3% of the vaccinated persons and systemic
reactions as fever, myalgia, dizziness or malaise were reported in < 4% of the
students.
CONCLUSION
• The main reservoir of rabies is the dog, which is responsible for almost
99% of fatal rabies cases in humans.
• Although the rabies vaccines available for animals are safe, immunogenic,
and efficacious when administered as recommended, vaccines that do not
contain proper immunogenic antigens should be identified and discarded.
• Lack of efficacy is also considered an adverse outcome of vaccination.
Although no vaccine can claim 100% efficacy, true lack of efficacy is
uncommon and failure to immunize is more likely to result from
inappropriate administration, pre-existing disease, immunosuppression, or
genetic non-responsiveness than to a problem with the vaccine itself.
Possible reasons behind the adverse effect of ARV observed in people of different age
group:
s behind the adverse effect of ARV observed in people of different age group:

• People of different age group have different immunity power.

• Elder people and children are not sufficient enough to produce
required antibody to combat antigen.
• Amount of antigen is higher than antibody produced by the body.
• Proper storage facility is not available while transportation and
distribution.
• Inappropriate mixing of dry ARV with its diluents.
• Patients with other associated medical illness.
Suggestion
• Physician should be watchful of adverse effects in prescribing rabies
vaccination especially in patients with a history of allergic conditions.
• In a people with suspected adverse reactions following rabies vaccine, a
thorough clinical assessment should be made to weigh benefits versus
risks of proceeding with rabies vaccination, bearing in mind that the
disease is deadly.
• Although it is impossible to completely prevent adverse reactions to
vaccines, the data presented here support the view that the benefits of
core vaccination against infectious diseases outweigh the low risk of an
adverse reaction.
QUESTIONNAIRES
• Name: Address:
• Gender: Male/Female Age:
Possible adverse effect that may be seen in the patients after
vaccination
a) Injection site reactions (pain, Yes No
swelling, itching, or redness)
a) Dizziness Yes No Medication Prescribed( If any):
a) Skin rash/ allergy Yes No
a) Nausea Yes No
a) Vomiting Yes No
a) Muscle pain Yes No
a) Restlessness Yes No
a) Weakness Yes No
a) Fever Yes No
a) Others: Specify:
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