1. Adverse events following immunization of pregnant
women with Yellow Fever Vaccine
in Kinshasa, DR Congo.
Didier Nzolo 1,2,3, Aline Engo Biongo2,3, Atinuke Olukemi Olaleye 4, Therese Mpiempe2,3, Gautier Mesia 2,3, Samuel Mampunza2,3, Gaston Tona2,3, Jean Pierre Van geertruyden1.
1 University of Antwerp, Antwerp, Belgium; 2 Unit of Clinical Pharmacology and Pharmacovigilance, University of Kinshasa, Kinshasa, DR Congo 3 National Pharmacovigilance Center, Kinshasa, DRC; 4. Department of Obstetrics and gynecology, Babcock University, Nigeria
Methods:
Background:
Data about the safety profile of vaccines during pregnancy are needed in order to assess the benefit-risk of vaccinating this vulnerable population. This study describes the most reported adverse events following immunization of pregnant women during a yellow fever outbreak in Kinshasa.
An active pharmacovigilance system at community level was set up by the DRC National Pharmacovigilance Center. Pregnant women attending antenatal care and willing to share their experience were interviewed by trained student from the Protestant University of Congo. Data collected included socio-demographic and obstetrics information, adherence to vaccination as well as experience and management of AEFI. Quantitative analyses were used to described the most reported Adverse Events Following Immunization (AEFI). Quantitative analyses identified themes for vaccine refusal and hesitancy as well as behavior following AEFI experience.
Results:
Figure 1 Sociodemographic and obstetrics characteristics of 333 Congolese pregnant women during YF vaccination campaign in August 2016
Table 1: Reported AEFI among 280 Congolese pregnant women after Yellow fever vaccination in August 2016
System and Organ Classification
Frequency (%)
N=280
TTO
Median
(IQR) [Range] PT
(Frequency; %)
Body as a whole - general disorders
35 (12.5)
1 (1, 2) [1, 3]
Asthenia (18; 6.4), Fever (10; 3.6), Malaise (5 ; 1.8), Oedema (1; 0.4), Oedema peripheral (1; 0.4)
Neurological disorders
21 (7.5)
1 (1, 1) [1, 4]
Dizziness (18; 6.4), Headache (3; 1.1)
Gastrointestinal disorders
19 (6.8)
1 (1, 1) [1, 3]
Nausea (10; 3.6), Abdominal pain (4; 1.4), Vomiting (3; 1.1), Diarrhoea (2; 0.7)
Application site disorders
8 (2.8)
1.5 (1, 2) [1, 3
Injection site (IS) pain (3; 1.1), IS pruritus (3; 1.1), IS reaction (2; 0.7)
Musculoskeletal disorders
4 (1.4)
2.5 (1, 4) [1, 4]
Back pain (3; 1.1), Arthralgia (1; 0.4)
Psychiatric disorders
2 (1, 3) [1, 3]
Anorexia (2; 0.7), Insomnia (2; 0.7)
Cardiovascular disorders
3 (1.1)
Palpitations (3; 1.1)
Reproductive disorders*
2 (0.7)
Uterine contractions (1; 0.4), Vaginal haemorrhage (1; 0.4)
Skin and appendages disorders
1 (1, 1) [1, 1]
Pruritus (2; 0.7)
Respiratory disorders
1 (0.4)
3 (3, 3) [3, 3]
Pharyngitis (1; 0.4)
Hearing, vestibular and special senses
Taste disorder (1; 0.4)
Table 2: Themes explored in the management of adverse events following immunization with yellow fever vaccine by pregnant women
Conclusion:
Themes
Exemplar quote
No case management
‘Nothing at all. I just set down and I slept’
‘Nothing except for rest’
Self-management without medication
‘I sat on a chair and requested a soft drink (Vital’O)’
‘I washed my face and I took water’
Self-management with pharmaceutical product
‘I have taken Novalgin but it has disturbed my stomach’
‘Massage with water and also usage of pomade for relief’
Discussion with own healthcare provider
‘I have contacted my physician and he prescribed me to take polygel’
Seeking care at health facility
‘I went directly to the hospital around 1 am’
‘Two days later, I went to the hospital’
Overall, the safety profile of YFV seems to be similar with the general population, except for some serious adverse events like uterine contraction and vaginal hemorrhage.
Acknowledgement:
To WHO/TDR and GSK for supporting my training in vaccine safety and this presentation
International Society of Pharmacovigilance 17th annual meeting, Liverpool 16 – 18 October 2017