|Year : 2016 | Volume
| Issue : 3 | Page : 131-136
Pattern of adverse events following immunization in nourished and malnourished infants in Kano, North-Western Nigeria
Umar Muhammad Lawan1, Gboluwaga Taiwo Amole1, Nafisa Yusuf Wali2, Mahmud Gambo Jahun3, Abubakar Mohammed Jibo1, Asmau Abdurrazaq Nakore4
1 Department of Community Medicine, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria
2 Department of Physiology, Bayero University, Kano, Nigeria
3 Department of Paediatrics, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria
4 Department of Community Medicine, College of Health Sciences, Bayero University, Kano, Nigeria
|Date of Web Publication||14-Oct-2016|
Umar Muhammad Lawan
Department of Community Medicine, Bayero University and Aminu Kano Teaching Hospital, P.M.B 3452, Kano
Source of Support: None, Conflict of Interest: None
Background: Adverse events following immunization (AEFI) occur in both nourished and malnourished babies but are often mislabeled as manifestations or complications of background condition or disease especially among malnourished infants. Aim/Objective: To study the pattern of AEFIs in nourished and malnourished infants in Kano. Materials and Methods: Descriptive cross-sectional design was used to study 372 eligible infants aged 0–11 months old. All infants immunized in the first quarter of 2014 that had up to date immunization card qualified for the study. Data were analyzed using SPSS version 16.0. Results: The mean age of the infants was 3.5 ± 3.1 months, with male being 53.5%, and well nourished being 88.4%. Prevalence of AEFI was 33.1% (nourished), 48.8% (malnourished), and 34.9% overall. Fever occurred in 79.8% nourished and 95.2% malnourished infants. Localized pains and/or swelling occurred in 29.3% nourished and 47.6% malnourished, but abscess or ulceration around vaccination site occurred only in the nourished infants and was significantly associated with the 1st immunization visit. Most AEFI were experienced around the 1st three immunization visits. Majority of the AEFI, experienced, nourished (58.7%), and malnourished (52.4%), occurred within 1–11 h and was mild to moderate in severity in 99.1% and 100% of the respective groups. Conclusion and Recommendation: Focused research on vaccine formulation and safety, and recurrent training of immunization workers on vaccine administration, and early and prompt treatment of AEFI are paramount.
Keywords: Adverse events, immunization, malnourished infants, Nigeria
|How to cite this article:|
Lawan UM, Amole GT, Wali NY, Jahun MG, Jibo AM, Nakore AA. Pattern of adverse events following immunization in nourished and malnourished infants in Kano, North-Western Nigeria. Sahel Med J 2016;19:131-6
|How to cite this URL:|
Lawan UM, Amole GT, Wali NY, Jahun MG, Jibo AM, Nakore AA. Pattern of adverse events following immunization in nourished and malnourished infants in Kano, North-Western Nigeria. Sahel Med J [serial online] 2016 [cited 2023 Sep 24];19:131-6. Available from: https://www.smjonline.org/text.asp?2016/19/3/131/192394
| Introduction|| |
It is globally acknowledged that immunization is one of the most important public health interventions especially in the fight against the spread of communicable diseases. By inoculating the killed or attenuated form of microorganisms through vaccination, the body immune system is stimulated to produce antibodies that will protect against infections. Malnutrition influences the immune status of children by impairing with nonspecific defenses and cell-mediated immunity in addition to thymic atrophy and diminished numbers of T helper and T cytotoxic lymphocytes that occur in severe cases of the condition., However, findings suggest that B-cell and antibody response in the malnourished is usually normal.,, Thus, except in cases of vaccines like bacillus calmette guerin (BCG) that act through stimulating cellular immunity, infants and children with malnutrition show a normal immune response to immunizations without a majoration of adverse events. Empirical evidence suggest that measles vaccine was both safe and effective in moderately malnourished infants and that no more side effect occurred than in well nourished.
Adverse events following immunization (AEFIs) may occur from program error during vaccine preparation, handling, and circumstances surrounding administration of vaccines. Local, systemic, or allergic reactions, on the other hand, may occur as a result of reactions to inherent properties of a particular vaccine even when prepared, handled, or administered correctly. In some cases, AEFIs occur from coincidental or unknown causes., Local vaccine reactions are common with inactivated vaccines and typically occur within a few hours of injection, transient, and self-limiting. So also, systemic vaccine reactions occur more commonly with live attenuated vaccines such as BGC, oral polio vaccine (OPV), measles, and yellow fever vaccines than with inactivated vaccines and may mimic a mild form of the disease., Allergic reactions are caused by the body's reaction to a particular component of a vaccine and may be neurological, for example, seizures, hypotonic-hyporesponsive episodes; or immune-mediated, for instance, idiopathic thrombocytopenic purpura, acute arthropathy, allergic reaction, and anaphylaxis. Allergic reactions occur rarely but can be life-threatening.,
AEFI monitoring and reporting system in Nigeria is still at the rudimentary stage. There are no clear guidelines for managing AEFIs in the majority of the immunization clinics, and cases of adverse events are often mislabeled especially in malnourished infants as manifestations or complications of background condition or disease. This has serious implication for the already dented immunization program in Northern Nigeria where people out of fear and concern for the safety of their children at one time rejected vaccinations en masse. This study assessed the pattern of AEFIs in nourished and malnourished infants in Central Kano and how the mothers responded to the events. Findings from this study will be useful for the health ministries, immunization program managers in Nigeria, and development partners supporting the program in packaging strategies for improved management of the immunization program in Nigeria. Because of the paucity of information on AEFIs in malnourished children in Nigeria, this study could also be useful for researchers as a foundation for further research.
| Materials and Methods|| |
Murtala Muhammad Specialist Hospital (MMSH) is one of the most attended secondary health facilities in Northern Nigeria, patronized by people from within and outside Kano State, as well as the neighboring Niger Republic. The immunization clinic operates 5 days in a week, vaccinating children under five against the common vaccine preventable diseases (BCG, diphtheria-tetanus-pertussis [DPT], OPV, hepatitis B vaccine, measles, and yellow fever) according to the Nigerian National Programme on Immunization guidelines and schedule, and attends to an average of about 180 patients daily.
Study design and subjects recruitment
Using a descriptive cross-sectional design, all the 372 eligible infants 0–11 months old that had up-to-date immunization cards out of the 9,841 children attended to in the immunization clinic of MMSH in the first quarter of the year 2014. The age group considered was to minimize recall bias while still allowing enough time to complete the immunization schedule.
Instrument and method of data collection
Pretested, structured, interviewer-administered questionnaires were used to determine the sociodemographic characteristics of the infant–mother sets, pattern of AEFIs including the types, manifestations, visits in which AEFI occurred, severity and period of onset of events, and how mothers responded to the AEFIs. The infants' nutritional status was assessed based on the World Health Organization reference values using their respective weights.
The questionnaires were administered by two trained interviewers after obtaining informed consent from the mothers. Literate respondents indicated acceptance by signing the consent form while illiterate participants affixed their thumbprint. Permission and ethical clearance for the study were also sought and obtained from MMSH and Ethical Committee of Kano State Hospital Services Management Board, respectively. Data were collected in July/August 2014.
Data were analyzed using SPSS for Windows, Version 16.0. (SPSS Inc., Chicago) computer statistical software. Absolute numbers and simple percentages were used to summarize categorical variables, whereas quantitative variables were summarized using means and standard deviation. The Chi-square test and Fisher's exact probability test were used for bivariate analysis involving categorical variables, and logistic regression analysis was used to determine predictors of AEFI in the infants. A P value ≤ 0.05 was considered statistically significant.
| Results|| |
All the mothers of the 372 eligible infants responded to the study questions giving a response rate of 100%.
Biological and demographic characteristics of the infants and their mothers
The mean age of the infants studied was 3.5 ± 3.1 months. The majority was male (53.5%), 1–6 months old (50.8%), and was delivered in the hospital/clinic (54.3%).
The mothers' ages ranged from 17 to 45 years with a mean of 27.2 ± 6.1 years, about two-thirds (63.7%) had at least secondary school education, and majority (64.3%) had one to four children [Table 1].
|Table 1: Biological and sociodemographic characteristics of the infants and their mothers|
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Pattern of adverse events following immunization
Majority of the infants studied were well nourished (n = 329; 88.4%), while the remaining 43 (11.6%) were malnourished.
The overall prevalence of AEFIs among both nourished and malnourished babies was 34.9%. The prevalence among the nourished and malnourished infants was 33.1% and 48.8%, respectively (Z = 1.86, P = 0.06).
We observed a slight variation in the types of AEFI experience between the two groups of infants. Although there were more variants of AEFIs among the nourished infants, it occurred in larger proportions among the malnourished babies. Fever was the most frequent systemic type of AEFI in all the babies and occurred in 79.8% and 95.2% of the nourished and malnourished infants, respectively. The other forms of systemic manifestations and allergic reactions only occurred in the nourished babies. Following bivariate analysis, it was observed that the prevalence of systemic or allergic AEFI was significantly associated with the 1st and 2nd immunization visits (P < 0.05) but not associated with the sex, age, or nutritional status of the babies. On multivariate analysis, however, none of the factors proved to be associated with the prevalence of systemic or allergic AEFI [Table 2].
|Table 2: Infant characteristics associated with prevalence of systemic and local AEFI|
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We also observed that the local reactions experienced by the infants were more varied in the nourished infants but occurred in higher proportions in malnourished infants. Pains and/or swelling around vaccination site was the more frequent form of local AEFI (nourished 29.3% vs. malnourished 47.6%), and abscess or ulceration around vaccination site was experienced only in the nourished infants [Table 3]. On bivariate analysis, we found that only the 1st immunization visit was significantly associated with the prevalence of local AEFI in the babies. The sex, age, and nutritional status of the babies were not significantly associated with the prevalence of local AEFI [Table 2].
Most of the AEFIs were experienced around the 1st three immunization visits in both the nourished and malnourished babies. From the highest to the least frequent, AEFIs occurred in 39.4%, 34.9%, and 22.9% of the nourished babies on the 2nd, 1st, and 3rd immunization visits, respectively. In the same fashion, it occurred in 38.1%, 33.3%, and 23.8% of the malnourished babies on the 3rd, 2nd, and 1st immunization visits, respectively, as shown in [Table 3]. None of the nourished and malnourished infants examined experienced any form of AEFI during the 5th immunization contact.
Majority of the AEFIs experienced by the nourished (58.7%) and malnourished babies (52.4%) occurred within 1–11 h and was mild to moderate in severity in 99.1% and 100% of the nourished and malnourished babies, respectively [Table 3]. Severity of AEFI was not statistically associated with the sex (Fisher's exact P = 0.08), age (Fisher's exact P = 0.51), and the nutritional status of the babies (Fisher's exact P = 0.19) nor with the 1st (Fisher's exact P = 0.38), 2nd (Fisher's exact P = 0.08), or 3rd immunization visits (Fisher's exact P = 0.75).
Mothers' responses to adverse events following immunization in infants
The actions taken by the mothers when their wards developed AEFI are summarized in [Table 4]. Most of the mothers used paracetamol and tepid sponging for treating the babies at home.
| Discussion|| |
The pattern of AEFIs noted in this study is similar to what was earlier noted in other parts of the country, with fever and pain or swelling at the injection site being most reported.
While some researchers have suggested that a relationship exists between malnutrition and immunologic response postvaccination, little is still known about the exact pattern of adverse events that may follow immunization in malnourished children.
One important finding of this study was the occurrence of fever following immunization in most of the malnourished infants and their nonexpression of other events such as generalized rash, convulsion, and loss of consciousness as observed among the nourished infants. In the same vein, a greater proportion of the malnourished children experienced local reactions such as pain or weakness at the injection site/limb. These findings may not be unconnected with the compromised immune status of the malnourished children. Contrary to the report from Ajjan et al., they also suggest that malnourished children may experience more AEFI than their nourished counterparts.
Although research on malnutrition and vaccination had dwelt more on the extent to which malnutrition affects vaccine efficacy, much of the evidence suggested that in most cases, there is little or no effect on the response or efficacy of the vaccines as their responses are mainly mediated through the humoral immune system., However, for some vaccines such as BCG and rotavirus, which act through a stimulation of the cellular immune system, malnutrition has been noted to alter the immunologic response and lower the efficacy of the vaccine.,
Although we observed that local reactions like pain and swelling around injection sites occurred in nourished and malnourished children, progression to abscess and/or ulceration occurred only among the nourished who are able to mount cellular immunity. This is corroborated by additional finding that local reactions were significantly associated with 1st immunization visits, a period when BCG vaccination is mostly given.
We also observed that fever was the most common systemic reaction in both the nourished and the malnourished, and these occurred most in the 1st three immunization visits corresponding to the period of administration of the DPT antigens.
Interestingly, the pattern in the frequency of occurrence of the fever in relation to the immunization visits varied among the nourished and the malnourished children. While in the nourished children frequency of fever increased from that of the 1st visit/1st dose or period of sensitization with the antigen, attaining the peak response by the 2nd visit/2nd dose, and diminished by the 3rd visit/3rd dose, expectedly after achieving full protection from the 2nd dose of the antigens, a step-wise increase in the frequency of fever from the 1st visit/1st dose to the 3rd was noted among the malnourished. This suggests a delay insero conversion possibly from impaired immunological response as a result of malnutrition.
The most common reason given by mothers for not completing their children's immunization was the adverse events the child experienced following the last immunization visit., Adverse events following the 1st or 2nd visit may partly explain the poor immunization indices of Northern Nigeria: The Northwest had very low vaccine coverage (10%), and DPT1 and DPT3 coverage for Kano State were reported as 26.2% and 18.9%, respectively, in the 2013 National Demographic and Health Survey. Thus, health talks given to mothers during antenatal care or at 1st immunization visit must be thorough and details of possible adverse events that may follow should be properly communicated to reduce dropout rates.
In view of the findings of this study, there is a need to focus research on vaccine development and formulation to improve its safety. Recurrent training for immunization workers on vaccine administration and early and prompt treatment of AEFI is paramount.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]
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