Background and Objective: Vaccines are medical devices used for boosting the health of people, especially children. This study was performed to determine the prevalence of the side effects of a new pentavalent vaccine in 2- to 6-month-old children in Ilam.
Materials and Methods: This descriptive cross-sectional study was performed on 2-6-month-old children for inoculating the pentavalent vaccine. A questionnaire containing queries on the age of child, parents’ education, contact number, injection date, gestational age, the underlying diseases, failure to thrive (FTT), and side effects (diarrhea, vomiting, nausea, redness, fever, intense crying, restlessness, drowsiness, stiffness, etc.).
Results: Of the children, 35.9% were two months old, 31.8% were four months old, and 32.3% were six months old. Boys and girls constituted 53% and 47% of children, respectively. Regarding mothers’ education, 54.5% had lower than diploma degrees, and 6.1% had academic education. Regarding fathers’ education, 13.2% had lower than diploma, and 12% had academic degrees. Most of the children (94.4%) had no underlying diseases, and 5.6% of them suffered from the underlying diseases including reflux (1.6%), anemia (2.3%), favism (0.9%), fever and convulsion (0.7%), and hypothyroidism (0.2%). The most common complications were fever (68.1%), skin redness (56.1%), pain (43.8%), and restlessness (24.7%). Fever (69.2% vs. 66.8%, P>0.05), skin redness (65.2% vs. 45.8%, P<0.05), vomiting (10.5% vs. 3.3%, P<0.05), and stiffness (6.6% vs. 3.3%, P>0.05) were more common in boys than girls, respectively. On the other hand, restlessness (35.8% vs. 14.8%, P<0.05) was significantly higher in girls than in boys.
Conclusion: According to our results, fever, skin redness, and pain were the most common complications. Fever was more common in 2-month-old boys, and pain was more observed in 6-month-old girls. Most of the side effects were transient and disappeared upon a week. No remarkable contraindications were reported, confirming the safety of the vaccine.