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“There are relatively few reports from the CIS in Lithuania. There are states where significantly more are reported if such events occur. There are several times more reports in the Scandinavian countries. The problem is that healthcare professionals are hardly involved in our reporting process. reports, ”Gytis Andrulionis, director of IWT, told a news conference on Friday.
“The problem continues to be that non-health professionals are the dominant link delivering those reports. The information that patients provide is less professional and needs to be clarified ”, complained the head of IWT.
The comirnaty rated the vaccine as the best
Dr I., Senior Advisor, Information Unit on Pharmacovigilance and Poisoning Rugilė Pilvinienė said that the higher the consumption of vaccines, the more reports of adverse reactions are received.
“We see that the Vaxzevria (AstraZeneca) vaccine, which was quite unpopular, is not the ‘bad’ vaccine – it has about 2 reports per 1,000 vaccinated people. We have received the fewest reports for every 1000 people vaccinated of the Comirnaty (Pfizer) vaccine; the figures are very tangible and highly appreciated. “We received the majority of the reports, a little more than 2, about the ‘Spikevax’ (‘Modern’) vaccine,” explained R. Pilvinienė.
In the third quarter of this year, IWT received 1,204 reports of suspected adverse reactions (ADRs) in Lithuania related to the use of COVID-19 vaccines. There were 636 adverse reactions after Comirnaty, 145 adverse reactions after Spikevax, 192 adverse reactions after Vaxzevria, and 225 reports after the COVID-19 Vaccine Janssen vaccine. The name of the vaccine was not mentioned in 6 NSAID reports.
R. Pilvinienė explained that the trends for all vaccines are similar.
The highest incidence of the Comirnaty vaccine is fever, headache, general weakness, chills, tiredness, muscle aches, nausea, bone and joint pain, and lymph node reactions. We have reports that both the axillary lymph nodes are enlarged after vaccination as well as other areas, such as the mandibular and cervical lymph nodes.
Multiple adverse reactions are commonly reported in a single report. The most common combinations are fever, headache, and chills. The most common side effect was pain at the injection site, ”he said.
The Spikevax and Vaxzevrios vaccines were reported to have received less from the reporting service. People who had been vaccinated the most with these vaccines complained of fever, chills, weakness, joint and muscle pain, and dizziness.
What do teenagers complain about?
R.Pilvinienė noted that the vaccination of adolescents, which began in the summer, did not lead to an increased flow of reaction reports. A total of 18 post-vaccination reactions have been reported in adolescents.
According to the specialist, these reports replicate general trends. Adolescents complain of fever, chills, general weakness, headache, drowsiness, fatigue, nausea, vomiting, diarrhea, and abdominal pain. The lymph nodes are also enlarged. Of note is the noticeable menstrual bleeding in girls and adolescents.
“Virtually all adverse reactions are included in the relevant sections of the Summary of Product Characteristics and the Package Leaflet,” emphasized R. Pilvinienė.
The 4 reactions reported were serious: myocarditis / pericarditis (2 cases in children aged 16 and 17 years), appendicitis and anaphylactic reaction.
However, the anaphylactic reaction, he said, can be seen as an immune response to the vaccine.
“It just came to our attention then. The adolescent has recovered from this reaction,” said the IWT specialist.
However, the IWT specialist questioned whether all the conditions were related to the vaccine. “The degree to which appendicitis is related to the vaccine is not very clear. As you know, appendicitis is a health condition that can occur without any vaccination. For both adults and teens. It is very likely that this case of appendicitis was completely accidental, ”said R. Pilvinienė.
Rare special reactions
“Reactions such as thrombosis and embolism should be mentioned. They have been reported after the use of Comirnaty and Vaxzevria.
Two cases of thrombophlebitis associated with Comirnaty have been reported. Thrombocytopenia, a decrease in the number of platelets involved in clotting, has been reported in two cases after this vaccine and in one case after Vaxzevrios. <...> As a result, there may have been bleeding, and in one case the person was bleeding as well, ”explained R. Pilvinienė.
The Office also received 5 case reports of myocarditis and pericarditis. All of them occurred after the second dose of the vaccine. As mentioned, 2 cases of pericarditis were reported in adolescents. It has also been observed that people have also complained of an increased heart rate after vaccinations and some have developed shingles.
The IWT spokeswoman said that among the reports received were adverse reactions such as fainting, peripheral paralysis of the face. Several deaths were also recorded in the third trimester after vaccination.
According to the specialist, most of them came after the administration of the Comirnaty vaccine. “None of the deaths were directly related to the side effects of the vaccine.
In all cases, the deaths were due to cardiovascular disorders. All the cases, except one in which the death occurred outside of Lithuania, were of the elderly, ”explained R. Pilvinienė.
Mostly mild reactions
According to the CBI, the majority of reports of suspected adverse reactions to COVID-19 vaccines received in the third quarter of this year were mild reports from the CNS, that is, 1,089 reports or 90.5%. 115 reports of severe CNS were received, representing 9.5%. of the total number of IRR notifications received during the analysis period.
When assessing the gender distribution of IRR reports received, it was found that about 66% of women reported RNA reports related to the use of COVID-19 vaccines (800 RMS reports for women and 400 reports for men, respectively) . The age range for CIS reporting individuals is 12 to 95 years old.
Health professionals accounted for only 12 percent of the total number of HRT reports. CNS reports, patients: 76 percent. and 12 percent. Notifications were received from the Eudravigilance database.
The main reports of CWD in COPD-19 vaccinated people who received IUDs remained the same: pain, swelling, and redness at the injection site, arm pain, chills, headache, rash, and fever. These reactions were generally mild to moderate in severity and resolved within a few days.
In the third quarter of this year, IWT received 7 reports of deaths after vaccination in Lithuania and one report of deaths after vaccination outside of Lithuania. In most cases, the deaths were due to diseases of the cardiovascular system. The causal relationship of these deaths to the vaccine has not been established.
IWT notes that the evaluation of the data in each CIS report is individual. The causal relationship of the suspected adverse reaction is evaluated according to certain criteria. Medical records are particularly important for the confirmation and evaluation of suspected adverse reactions. Information is also needed on what chronic or other diseases the person had prior to vaccination, as well as data on other indicators of their health status.
