In this study, we compared the side effects of vaccina-tion in children with Type-1 DM and healthy children without any disease. There was no difference in vaccination side effects in Type-1 DM patients compared to healthy children. Only the severity of pain at the injection site and the frequency and severity of head-aches were greater in patients with Type 1 DM diagnoses.
Children and adolescents with T1DM should be vac-cinated according to the recommended immunization program for healthy children. Pneumococcal vaccines may also be needed, and flu vaccines should be admin-istered rigorously each year 19.
The COVID-19 pandemic, which has gripped the entire world for nearly 2 years, is particularly heavy-handed in people with chronic illnesses 20. Several recent studies have shown that both poorly controlled patients with Type-2 diabetes and Type-1diabetes are more vulnerable to serious diseases following COVID-19 compared with people without diabetes 21-23.
Vaccination of children/adolescents is seen as important for ending the pandemic by helping the world make significant progress to gain herd immunity 24. Vaccination has been recommended by the American Academy of Paediatrics as the benefits of COVID-19 vaccination in children between the ages of 12 and 17 are greater than the risks of possible side effects 25.
It has been reported that COVID-19 vaccine hesitancy in Turkey is at a high level, with 31% of vaccine hesitancy 26. The concerns about the COVID-19 vaccine are the safety of the vaccine, lack of trust in vaccines and/or pharmaceutical companies, inadequate knowledge of a new vaccine, and especially long-term potential side effects 27,28. Although about 60.40% of the U.S.A adult population has been fully vaccinated by the end of July 2021, only 33% of 12-17-year-olds were vaccinated against COVID-19 in the same period, and 25% of parents said they would definitely not get their children vaccinated 29,30. One study reported a 40% vaccine hesitancy rate against the COVID-19 vaccines in parents of children and adolescents younger than 18 31. Another study reported that 21.30% of parents of young adolescents with chronic illnesses had vaccine hesitancy 32. In the study of Akarsu B. 33, the proportion of people who say they will not get vaccinated because of the side effects of vaccines is 27.70%, while the proportion who say they will not get their children vaccinated due to side effects falls to 11.90%.
Although allergic reactions to vaccination are a common concern, rates of vaccine-related allergic reactions are not high and many of them are not serious. In fact, the risk of anaphylaxis for many vaccines is very low (1 in 1,000,000 doses) 34. Overall, FDA and CDC reports note that the risk of serious side effects involv-ing organs is balanced between placebo and vaccine groups 35. Our study results are in line with the lit-erature which reports that there are no cases of serious adverse effects related to vaccination in both doses.
Local reactions such as pain at the injection site are responsible for most of the complaints, while system-ic/severe reactions are rare 36. Reactions are often self-limiting and reported more often after 2nd dose compared to the 1st dose 37,38. In the study of See ML, among all vaccinated people between the ages of 12 and 15, 90.90% reported at least one local injection site reaction within 7 days of vaccination. Pain at the injection site was the most frequent local reaction in this study and was a little more prevalent after the 2nd dose 39. In our study, the most common side effect among all participants was pain at the injection site with 88.20%, while swelling was 26.50% and redness was 17.60%. The side effects were more common in the patient group after 1st dose and in the control group after 2nd dose, although causing no statistically signifi-cant difference (p =0.07). It's worth noting that most observed reactions are low or medium in severity, which coincides with reports on vaccine safety 36.
Headache, which occurs relatively frequently after vaccination, has been reported as a notable systemic side effect in the range of 23.80-55% 12,13,36. In our study, it was the 2nd most common (27.90%) side effect (44.10% of the patient group and 11.70% of the control group).
The severity of the pain at the injection site and the frequency and severity of the headache complaint were higher in the patient group, while the rates of postvaccine painkiller use were similar in both groups. It did not cause further analgesic use, which suggested that differences between them might be associated with the relative defining and that it had little clinical significance.
Fever is reported to have a frequency of 18-48% and is generally responsive to antipyretics 37,40. In our study, 17.60% of all participants reported fever, which was compatible with the literature.
It's worth noting that participants were asked to identify past negative events. Because there may be side effects that they forget or misidentify. A community-based survey would also be more appropriate for this type of study. However, as social distance is still highly recommended, we preferred to conduct this study as web-based research to ensure the safety of all our study participants. There are no other studies reporting the occurrence of adverse reactions related to the COVID-19 vaccination in the population of children with Type-1 DM in Turkey. Studies with wider participation will continue to contribute to this issue.
The limitation of our study is that our number of patients was low. The side effects seen in the patients are not based on the observation and examination of the doctor. Because it is a retrospective study, the accuracy of the answers to the questions is based on the statements of the patients and their parents.
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