311 adverse reactions to COVID-19 vaccines were reported, 13 of which were serious



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Speaking of the vaccines used by two manufacturers so far, Pfizer-BioNTech and Moderna, Gytis Andrulionis, head of the State Agency for Medicines Control (VVKT), reported that within a month from December 26. 68 thousand have already been vaccinated. 491 person.

The number of vaccinations itself was higher by 84 thousand. 586 because some people have already received a second dose.

“During this period, out of that number of people vaccinated, the ICD received 311 initial reports of adverse drug reactions in Lithuania. And that’s 0.37 percent. of the number of vaccinated doses, ”he said.

According to G. Andrulionis, we are not too different from any other country in these figures.

According to him, there were 297 reports of the Pirer-BioNTech Comirnaty vaccine and 13 reports of the Moderna vaccine.

“This is because the vaccination with this vaccine only started on January 18. And for reports, there are 15 and 9-10 days after an adverse reaction, respectively, so not all of those reports may have been put together. We receive the majority of reports from patients. I’ll just remind you that the first groups to get vaccinated were healthcare workers. It is that above all they like patients and they fill up. Mild reactions to the vaccine accounted for the vast majority, 284 for Comirnaty and 13 for Moderna. We also have 13 difficult reactions, ”said G. Andrulionis.

The vast majority of the reports were submitted by women. This, he said, is due to the fact that more of them work in health facilities. In addition, as the elderly have been vaccinated in healthcare centers and women have a longer life expectancy, more vaccinations and reactions are being recorded.

Many side effects are mild

The director of IWT has said that the possible side effects of the three vaccines registered in the European Union are similar.

These include pain, swelling at the injection site, tiredness, headache, general malaise, fever, nausea. In the case of Pfizer and Moderna, acute peripheral facial paralysis is also identified, as well as hypersensitivity reactions and anaphylaxis have been observed in several individuals ”, he said on the TV3.lt program“ Dienas pjūvis ”.

According to G. Andrulionis, information on the possible side effects of the drug is refined during registration and published in the drug’s package insert.

Rugilė Pilvinienė, senior advisor to the IUD Pharmacovigilance and Poisoning Unit, said fever was most frequently reported when body temperature was above 38 degrees, detailing adverse reactions to the Comirnaty vaccine.

Vaccine

“Such a reaction was reported in a third of the reports, around a hundred. Headaches have also been frequently reported. However, as a general rule, if a person has a high fever, they will also have a greater headache.

Fever has also been reported when the temperature is below 38 degrees. (…) Cases of intense fever were accompanied by chills. Cases of general weakness are also correlated with this information. Injection site reactions have also been reported in most people. Pain or discomfort at the injection site has been reported frequently, but other reactions include redness and swelling. Some reported symptoms of allergic reactions, ”he said.

There are no such large numbers for the “modern” vaccine; only a few cases have been reported. The most frequent reactions were also fever, chills, feeling cold, eye pain, which, according to the specialist, may be associated with fever again.

At the same time, R. Pilvinienė pointed out that the more people are vaccinated, the more reports are received, it is not scientifically possible to compare the small scale of adverse reactions caused by a vaccine.

“Nor is our goal to compare the safety of these vaccines because we have very little information about a vaccine. Once we have such information that it is already possible to compare, then perhaps it is possible to see what trends. And maybe there are no big differences, “he said.

A reaction similar to anaphylaxis has also been reported.

Commenting on the suspicions of serious adverse reactions, the representative of the IWT recalled that according to the foreseen legislation, they are considered reactions that require hospitalization or prolongation. Also if the person dies as a result of an adverse reaction or if birth defects or other conditions have occurred during the pregnancy.

“It just came to our attention then. As is well known, this vaccine is not recommended during pregnancy and we do not know which pregnant women should be vaccinated.

So in this case, we consider a severe reaction if that event was of significant importance and if the person needed hospital care. These are some obvious trends that I couldn’t pinpoint due to serious suspected side effects.

However, these reactions included severe headaches, dizziness, and the couple fainted or felt weak. Also, nausea, severe vomiting. One side effect was reported as anaphylaxis: the person became weak and had low blood pressure. However, we still cannot say, because such reactions also occur with a psychogenic effect, a needle. This is also written in the summary of characteristics of the vaccine ”, explained the IWT specialist.

He added that reactions such as palpitations, shortness of breath and a strong local reaction also occurred.

“One patient had very severe swelling of the lymph nodes and severe pain in the armpit. As I mentioned, this is a common reaction to vaccines. There were also reports of severe pain in the muscles of the arm and the whole body, ”said R. Pilvinienė.

Sudden deaths were recorded a week after vaccination with COVID-19, but experts consider this a coincidence.

He also added that unexpected reactions to the vaccine included numbness of the tongue, face or extremities.

“However, there were very few such cases, only a few. Several reported numbness of the face, several reported dissolution of the tongue and loss of sensation. Some reported numbness on one side of the face, some in the numbness of the face. hand, ”he said.

Among the unexpected reactions not mentioned in the summary of product characteristics, R. Pilvinienė also attributed cases of increased blood pressure. There were a dozen of them, similarly recorded by an increase in heart rate.

“We treat it as an unexpected reaction when the heartbeat occurred in the absence of other possible causes,” said the specialist.

Reactions are similar to those seen after influenza vaccination.

In turn, the infectologist, Professor Arvydas Ambrozaitis, assured that the mentioned percentage of registered side effects is similar to vaccines with other vaccines, such as the influenza vaccine.

“It just came to our attention then. All of these reactions are very common, such as headaches, joint pain, muscle pain, injection site pain; we know this with other vaccines. Perhaps only slightly less common is the Temporary numbness or acute peripheral facial paralysis This may be a bit unexpected, but it is very rare.

According to data from clinical trials with Pfizer, this numbness or, as some write, temporary paralysis, was seen in only four people who received the vaccine and not in the placebo group. But such temporary facial paralysis does not cause any health problems and goes away. So I would say that the vaccine is very safe, “he said during the” Section of the Day “program.

Currently, the vaccines are registered in the European Union by three manufacturers: Pfizer-BioNTech, Moderna and AstraZeneca. Vaccines from the latter company should arrive in Lithuania by the end of this week.

Last day, 1,491 people received the first dose of the vaccine and 4,291 people received the second dose.

In Lithuania, the first dose of the COVID-19 vaccine was administered to a total of 75,000 people. 804 people, both doses – 30 thousand. 241 people.

New cases 721

Last day, 721 new cases of COVID-19 were detected in Lithuania, 12 people died, the Department of Statistics reported on Thursday. Additionally, six more coronavirus deaths were included in the overall death statistics when the actual date of death is earlier.

Last day, 1,442 people recovered from COVID-19.

In Lithuania, since the start of the pandemic, COVID-19 has affected 184 thousand people. 948 people, 133 thousand. 994 people recovered, 45 thousand. 753 – tebeserga.

1,324 COVID-19 patients are currently being treated in Lithuanian hospitals, 153 of them in resuscitation, additional oxygen is supplied to 1,009 patients and artificial lung ventilation is applied to 84 people.

114 patients were hospitalized for COVID-19 on the last day.

2,885 people have died from coronavirus in the country.

There were 8,855 suspected coronavirus tests in the country last day, for a total of 1 million cases since the start of the pandemic. 957 thousand 327.



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