Adverse Post-Vaccination Events to BCG in Cacoal City, Rondonia, Brazil - 2016-2018 Period à BCG No Cacoal,

— The Calmette-Guérin Bacillus (BCG) vaccine is used against severe forms of tuberculosis. Although BCG post vaccination adverse events (EAPV) are uncommon, when identified they should be reported. The objective was to characterize the EAPV to BCG in the Municipality of Cacoal / RO from 2016-2018. This is a documentary, cross-sectional and descriptive study of quantitative approach, conducted with secondary data obtained from the reporting / investigation forms of AEFI to BCG, in the period 2016-2018 of individuals residing in Cacoal / RO. The population consisted of 13 notification forms, and they were part of sample 11, since 02 met the exclusion criteria. Data were collected through a collection instrument prepared by the researchers and the project was executed after authorization by the Municipal Secretary of Health and CEP under CAAE No. 2556919.0.0000.5298. During the study period, 4,677 individuals were vaccinated with BCG, data collected through the SI-PNI. Of the 11 AEFIs reported, 7 were male and 4 female. The AEFIs identified with the respective proportion of cases in the study population were: cold subcutaneous abscess (2.67: 2.500), non-suppurative regional lymphadenopathy (1.6: 2.500), warm subcutaneous abscess (1.07: 2.500) and lymphadenopathy. regional suppuration (0.5: 2,500). Among the 11 cases studied, 04 did not follow the AEFI management protocol. It was concluded that VAPA to BCG predominated in males, in children younger than 1 year old and that cold subcutaneous abscess, non-suppurative regional lymphadenopathy and warm subcutaneous abscess are above the standard recommended by NIBP.


Resumen-La vacuna Calmette-Guérin Bacillus (BCG) se usa contra formas graves de tuberculosis. Aunque los eventos adversos posteriores a la vacunación con BCG (EAPV) son poco frecuentes, cuando se identifican, deben informarse. El objetivo fue caracterizar el EAPV a BCG en el
The usual time for BCG to evolve is 6 to 12 weeks, and may rarely extend until the 24th week. During the normal course of the vaccine lesion, axillary and supra or infraclavicular ganglionic infarction may occur, single or multiple, without suppuration. The lymph node appears three to six weeks after vaccination, it is homolateral to the application site, firm, mobile, clinically very noticeable, cold, painless, measuring up to 3 cm in diameter and not accompanied by general symptoms. It can evolve for a variable time, usually around four weeks and remains stationary for one to three months (BRASIL, 2014a).
Although adverse events to BCG are not frequent, every vaccinated individual may develop an adverse event after vaccination (AEFI), which are undesirable clinical situations, which can occur in people who have received some type of immunobiological. Regarding immunobiologicals, the vast majority can develop AEFV, which are considered mild, such as fever and local reaction, they can also develop as moderate and severe, leading to the individual's hospitalization and disability, and even death (SILVA et al., 2016).
Among the expected events, we can have relatively trivial events, such as: fever, pain and local edema; or more serious events, such as: febrile seizures, among others. Unexpected events are those arising from problems related to product quality, such as contamination of lots; causing local abscesses, or undue endotoxin content in certain vaccines, leading to feverish reactions and sepsis-like symptoms (BRASIL, 2014a).
Three basic points are used for the investigation of an adverse event, namely: factors related to the vaccine, factors related to vaccines and factors related to administration (BRASIL, 2014a).
Serious adverse events after vaccination are part of the national list of Compulsory Notification diseases / diseases, that is, it is mandatory to be notified, and any health professional who identifies the adverse event is responsible for this notification (BRASIL, 2016).
Given the above, this research is relevant, as the data collected in this study regarding the characterization of adverse events to BCG, as well as the proportion of these events, will serve as a basis to identify whether these adverse events are within the parameters expected by the Ministry of Health (MS) ), as well as serving as a subsidy for the development of actions to improve the quality of care provided, together with the National Immunization Program (PNI), with regard to the BCG vaccine.
This work aims to characterize the adverse events after BCG vaccination in the municipality of Cacoal / RO in the period 2016-2018, according to gender and age, to identify the proportion of these events for correlation with the normal parameters of the PNI, to classify the types adverse events according to the signs and symptoms presented and verify the evolution and conclusion of the reported adverse events.

II.
MATERIALS AND METHODS This is a documentary, cross-sectional and descriptive study with a quantitative approach, carried out with secondary data obtained through the notification / investigation forms of adverse events after vaccination of patients who presented some type of adverse event after BCG vaccination, in the period from January 2016 to December 2018, of residents in the municipality of Cacoal / RO.
The study population consisted of 13 patients who had an adverse event to the BCG vaccine in the period proposed by the study and were notified by means of the notification / investigation form of adverse events after vaccination, with the sample consisting of 11 patient notifications, as 02 were excluded from the study, as they met the exclusion criteria, as they were not vaccinated in Cacoal and do not reside in the municipality.
As inclusion criteria, they were determined by means of notification / investigation forms of adverse events after vaccination and medical records of patients residing in the municipality of Cacoal / RO and who presented some type of adverse event after vaccination to BCG, in the period from January 2016 to December 2018. As exclusion criteria, medical records with illegible handwriting, adverse event notification forms to BCG with illegible handwriting and adverse event notification forms to other vaccines, which were not BCG, were determined .
The data collection questionnaire was developed by the researchers, containing 07 closed questions and 06 open questions, with information about the gender and age of the study population and variables related to the notified AEFI, namely: proportion of reported adverse events that will be correlated with the expected events standardized by the Ministry of Health through the PNI, classification of the AEFIs reported according to the signs and symptoms presented, classification of the evolution of the case and Access to patients' medical records was made impossible due to the lack of computerization in basic health units, which made it impossible to locate them.
After data collection, they were arranged in tables, using Microsoft Office® programs (Word 2013 and Excel 2013). Descriptive statistics were used, using mean, relative frequency, absolute frequency and proportion calculation.
To carry out the research in accordance with Resolution 466/12 of the National Health Council, it was necessary to approve the Ethics and Research Committee

III.
RESULTS AND DISCUSSIONS The present study was carried out by analyzing 11 (100%) of notification / investigation forms of adverse events after BCG vaccination performed in the municipality of Cacoal. Since the number of cases notified in 2016 was 05 (45.5%) cases, 05 (45.5%) in 2017 and 01 (9%) in 2018.
According to the study, among the 11 reported cases (100%), 04 (36.4%) were female, and 07 (63.6%) were male. The average age of vaccinated individuals who experienced an adverse event in this period was 01 month and 16 days, the minimum age was 03 days and the maximum age 04 months and 27 days.
A study carried out in Recife / PE in 2017, showed the incidence of adverse events after vaccination in children, among which 373 AEFIs were identified, with 83.90% adverse events temporarily related to the vaccine (EATV) and 16.10% to errors immunization (IS). The most frequent occurred in male children and under one year old (BRAGA, 2017).
Although the BCG vaccine is also indicated for contacts of patients with leprosy, in which it can be administered to individuals older than 1 year according to the MS protocol (BRASIL, 2016), there were no cases of adverse events to BCG in the age group of adult individuals. This may be related to the fact that the adult individual is more resistant to going to the vaccination room to refer to an adverse event or to other factors, because according to Brasil (2014c), the adverse events may be related to the individual's immune system. Another factor may be related to the ease of administration of BCG in an adult individual, when compared to administration to a newborn, who has thinner and more sensitive skin for administration of the immunobiological agent intradermally.
The collected data resulted in 04 types of adverse events to the BCG vaccine, being cold subcutaneous abscesses, hot subcutaneous abscesses, non-suppurated regional lymphadenopathy and suppurated regional lymphadenopathy. Of the 11 (100%) cases of AEFI to BCG reported during the study period 05 (45.5%) were of the type cold subcutaneous abscesses, 03 (27.3%) unsuppurated regional lymphadenopathy, 02 (18.2%) hot subcutaneous abscesses and suppurated regional lymphadenopathy, 01 (9%). The main symptoms presented in the notification forms were nodule, abscess and pain related to the four types of adverse events. Other symptoms were observed, such as fever, erythema, flushing and regional adenopathy, among others. Among the 04 types of adverse events, 03 presented the use of Isoniazid as conducts, as shown in table 01. Table 01 also presents data on the final classifications of AEFIs to BCG, in which they presented four types of manifestations, namely, local, systemic skin / mucosa clinics, systemic / respiratory clinics and systemic / neurological clinics. Among the manifestations presented, the most prevalent was the local manifestation, followed by the systemic clinical manifestation / skin and mucosa. It is noted that health professionals are aware of the attendance, notification and follow-up of BCG-related adverse events, as all reported events presented in table 1 are part of the compulsory notification adverse events according to the conduct to be adopted in the Manual. of adverse events to immunobiologicals (BRAZIL, 2014b).

International Journal of Advanced Engineering Research and Science (IJAERS)
[ Regarding the behaviors adopted by health professionals regarding what is advocated by the MS through the PNI, it is noted that health professionals need to have greater knowledge of the protocols established by the program, given that some behaviors adopted in relation to AEFIs do not according to Brazil, according to Brazil (2014b), the cases of AEPS of non-suppurative regional lymphadenopathy and hot subcutaneous abscess is not indicated for use of isoniazid, but it is noted as a conduct, the prescription and use of medication, and in one of the cases of cold subcutaneous abscess that indicated the use of isoniazid according to the protocol, it was not prescribed.
According to the 2014 AEFI epidemiological surveillance manual, BCG is naturally resistant to pyrazinamide. The Moreau Rio de Janeiro strain is isoniazid sensitive, so administration of isoniazid is used as the gold standard for treatment (BRASIL, 2014a).
Regarding the classification of AEFIs to BCG, local clinical manifestations, and systemic clinical manifestations / skin and mucous membranes were the most predominant. Local manifestations are the most common in cases of AAPV to BCG and are considered at or near the site of administration and may occur after application of any vaccine. These reactions are consequences of the introduction of the needle and the vaccine content into muscle tissue, hyperesthesia, reactive vasodilation, pruritus and urticarial papules and ganglionic infarction. This may cause an abscess at the site of administration, cellulitis, near hardening or at the site of administration, near edema or at the site of administration, lump and pain (BRASIL, 2014a).
Systemic manifestations can be defined as an acute hypersensitivity reaction, with involvement of multiple systems being considered of greater severity (BRASIL, 2014a). Table 2 shows the proportion of reported AEFIs in the municipality of Cacoal during the study period compared to the proportion of AEFIs recommended by the MS through the NIP, and the cold subcutaneous abscess type AEFIs presented 2.67 cases for every 2,500 vaccinated, followed by unsuspected regional lymphadenopathy, the number of cases was 1.6 for every 2,500 vaccinated. Hot subcutaneous abscess adverse events presented 1.07 cases for every 2,500 vaccinated patients, while the proportion of suppurative regional lymphadenopathy adverse events was 0.5 cases for every 2,500 vaccinated.
The MS through the PNI, recommends that for every 2,500 vaccinated, 01 individual will present adverse event to BCG (BRAZIL, 2014a). Among the results obtained, three types of adverse events were above the recommended standard, only the suppurative regional lymphadenopathy adverse event was below the EAPV expected by the PNI. According to Brazil (2014a), BCG vaccine has been used for decades and is the main form of prevention of severe forms of TB, but may cause local, regional or systemic adverse events, and local and regional adverse events such as abscess, lymphadenopathy. regional suppuration greater than 3 cm, regional suppurative lymphadenopathy may be directly linked to incorrect vaccine administration technique.
Note the importance of nurses working directly in the vaccine room, because they are responsible for their nursing staff, being important their training and constant updating, as well as promoting continuing education for their team.

IV.
FINAL CONSIDERATIONS Taking into account the above data, it was observed that males were the most affected by adverse events to BCG and the prevailing age was in children under 01 (one) year. It was found that VAPE of cold subcutaneous abscess, hot subcutaneous abscess and non-suppurative regional lymphadenopathy are above the standard recommended by the NIBP, and only the adverse event of suppurative regional lymphadenopathy is within the recommended.
It is suggested a proposal for the study presented, where professionals who attend the AEFI are constantly trained and updated to attend and follow up these cases, and that professionals who work directly with immunization are regularly trained regarding errors of immunization,