Analysis of adverse events following immunization caused by immunization errors

this is a descriptive, documental, retrospective, and quantitative research using secondary data from the Adverse Event Following Immunization Information System and the Immunization Program Evaluation System. We included cases confirmed and/or associated with different types of vaccines. For the analysis, we collected frequencies and incidence rates, and used simple linear regression models with Student's t-test.

Results:

it was observed an AEFI increase due to immunization errors, especially hot subcutaneous abscesses. BCG vaccine had the highest incidence of adverse events and children under one year old were the most affected individuals.

Conclusion:

the current scenario is worrisome because these are preventable AEFI - injuring patients due to bad vaccination practices - that may undermine the population's confidence, reducing immunization coverage, and the progress in the control of vaccine-preventable diseases.

Descriptors:
Vaccination; Medication errors; Nursing; Public health nursing; Immunization

Year	Cold subcutaneous abscess		Hot subcutaneous abscess		Regional nonsuppurative lymphadenitis > 3 cm		Regional suppurative lymphadenitis		Ulcer > 1 cm		Total
	n = 177		n = 246		n = 51		n = 95		n = 35		N = 604
	%	IR	%	IR	%	IR	%	IR	%	IR	%	IR
2003	34.5	0.15	20.7	0.09	20.7	0.09	13.8	0.06	10.3	0.05	100	0.44
2004	42.1	0.20	18.4	0.09	5.2	0.02	26.3	0.12	7.9	0.04	100	0.46
2005	27.8	0.14	33.3	0.17	13.9	0.07	19.4	0.10	5.6	0.03	100	0.51
2006	39.3	0.17	21.4	0.09	3.6	0.02	28.6	0.13	7.1	0.03	100	0.44
2007	37.5	0.18	15.6	0.07	9.4	0.04	37.5	0.18	0	0	100	0.48
2008	31.4	0.10	17.1	0.05	11.4	0.04	34.3	0.11	5.7	0.02	100	0.31
2009	39.4	0.19	15.2	0.07	15.2	0.07	21.2	0.10	9.1	0.04	100	0.48
2010	19.4	0.08	22.6	0.09	12.9	0.05	29.0	0.12	16.1	0.06	100	0.40
2011	29.8	0.35	45.2	0.53	9.5	0.11	6.0	0.07	9.5	0.11	100	1.18
2012	30.4	0.42	53.2	0.76	5.1	0.07	6.3	0.09	5.1	0.07	100	1.38
2013	21.8	0.73	62.6	2.10	5.0	0.17	8.9	0.30	1.7	0.06	100	3.36
Total	29.3	0.23	40.7	0.32	8.4	0.07	15.7	0.12	5.8	0.05	100	0.78

Immunobiological agent	2003	2004	2005	2006	2007	2008	2009	2010	2011	2012	2013	Total
	n = 29	n = 38	n = 36	n = 28	n = 32	n = 35	n = 33	n = 31	n = 84	n = 79	n = 179	N = 604
	IR	IR	IR	IR	IR	IR	IR	IR	IR	IR	IR	IR
BCG	12.20	18.40	17.90	13.50	18.30	18.60	17.60	15.80	29.40	18.90	30.81	19.14
DTP/HB/Hib^* * IR: Incidence rate;	-	-	-	-	-	-	-	-	-	1.69	8.60	7.14
DTP/Hib^* * IR: Incidence rate;	0.82	0.42	0.21	0.87	0.22	0.69	0.67	0	3.23	3.33	-	0.98
HATIG	0	0	0	0	0	0	0	0	0	72.8	0	7.12
IPV	0	0	0	0	0	0	0	0	0	5.83	6.95	6.86
PPSV23	0	0	0	0	0	0	0	15.80	26.00	7.78	7.17	5.43
DTP	1.34	0.38	0.66	0.36	0	0	0	0.40	1.98	2.16	2.92	0.89
PCV10^* * IR: Incidence rate;	-	-	-	-	-	-	-	0	0	0.87	2.02	0.78
Td	0	0.25	0.11	0.14	0	0.10	0.29	0.27	0.81	0.44	5.73	0.46
IV	0	0	0	0	0	0	0	0	0	1.93	7.17	0.41
Men-C	0	0	0	0	0	0	0	0	0.20	0.23	0.23	0.20
HB	0.10	0	0.11	0	0.14	0	0	0.14	0.40	0.42	0.68	0.17
YF	0	0.21	0	0	0.29	0	0	0	0.33	0.24	0.99	0.15
RV	17.60	0	0	0	0	0	0	0	0	0	0	0.13
MMR	0	0	0	0	0	0.03	0	0	0.27	0.31	0.87	0.09

Immunobiological agent	Cold subcutaneous abscess		Hot subcutaneous abscess		Regional nonsuppurative lymphadenitis > 3 cm		Regional suppurative lymphadenitis		Ulcer > 1cm		Total
Immunobiological agent	%	IR	%	IR	%	IR	%	IR	%	IR	%	IR
BCG	41.3	7.90	6.1	1.17	14.8	2.84	27.6	5.29	10.2	1.95	100	19.14
DTP/HB/Hib^* * vaccines not available in the PNI/MS vaccination calendar in those years;	22.5	1.61	77.5	5.53	0	0	0	0	0	0	100	7.14
DTP/Hib^* * vaccines not available in the PNI/MS vaccination calendar in those years;	25.0	0.25	75.0	0.74	0	0	0	0	0	0	100	0.98
HATIG	0	0	100	7.12	0	0	0	0	0	0	100	7.12
IPV	0	0	100	6.86	0	0	0	0	0	0	100	6.86
PPSV23	0	0	100	5.43	0	0	0	0	0	0	100	5.43
DTP	7.7	0.07	92.3	0.83	0	0	0	0	0	0	100	0.89
PCV10^* * vaccines not available in the PNI/MS vaccination calendar in those years;	17.6	0.14	82.4	0.64	0	0	0	0	0	0	100	0.78
Td	10.5	0.05	89.5	0.41	0	0	0	0	0	0	100	0.46
IV	8.1	0.03	91.9	0.38	0	0	0	0	0	0	100	0.41
Men-C	0	0	100	0.20	0	0	0	0	0	0	100	0.20
HB	14.3	0.02	85.7	0.14	0	0	0	0	0	0	100	0.17
YF	0	0	100	0.15	0	0	0	0	0	0	100	0.15
RV	0	0	100	0.13	0	0	0	0	0	0	100	0.13
MMR	14.3	0.01	85.7	0.08	0	0	0	0	0	0	100	0.09
Total	29.3	0.33	40.7	0.46	8.4	2.84^* * vaccines not available in the PNI/MS vaccination calendar in those years; ^* * vaccines not available in the PNI/MS vaccination calendar in those years;	15.7	5.29^* * vaccines not available in the PNI/MS vaccination calendar in those years; ^* * vaccines not available in the PNI/MS vaccination calendar in those years;	5.8	1.95^* * vaccines not available in the PNI/MS vaccination calendar in those years; ^* * vaccines not available in the PNI/MS vaccination calendar in those years;	100	1.12

Age group(in years)	Cold subcutaneous abscess	Hot subcutaneous abscess	Regional nonsuppurative lymphadenitis > 3 cm	Regional suppurative lymphadenitis	Ulcer >1cm	Total
	n = 177	n = 246	n = 51	n = 95	n = 35	N = 604
	%	%	%	%	%	%
< 1	78.5	47.6	100	95.0	82.9	70.5
1	6.8	11.0	0	5.0	11.4	7.9
2	4.0	2.0	0	0	5.7	2.3
3	3.4	2.8	0	0	0	2.2
4	1.1	6.5	0	0	0	3.0
5 l-l 10	1.1	5.7	0	0	0	2.6
11 l-l 14	0.6	0.8	0	0	0	0.5
15 l-l 19	0	1.6	0	0	0	0.7
20 l-l 24	0	1.6	0	0	0	0.7
25 l-l 29	1.1	0.8	0	0	0	0.7
30 l-l 39	1.7	5.3	0	0	0	2.6
40 l-l 49	0	5.7	0	0	0	2.3
50 l-l 59	1.1	6.5	0	0	0	3.0
60 and older	0.6	2.0	0	0	0	1.0
Total	100	100	100	100	100	100

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[1] CORRESPONDING AUTHOR: Lúcia Helena Linheira Bisetto. E-mail: lubisetto@gmail.com