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“The number of adverse reactions to vaccines is decreasing as the vaccination rate is slowing down,” said Gytis Andrulionis, director of the State Agency for Drug Control (IARC).
According to him, in the sixth month of vaccination, IWT received 736 reports of suspected adverse reactions (ADRs) in Lithuania related to the use of COVID-19 vaccines. There have been 395 reports of ERC after the Comirnaty administration; 100 ADRs were received after Spikevax (Moderna) administration and 169 ADRs after Vaxzevria. The COVID-19 Vaccine Janssen vaccine has received 69 reports from CNS.
Two myocarditis and reports of minors
689 messages are classified as mild to moderate, 37 are classified as severe.
As in previous months of vaccination, women reported more cases of IR than men, with 489 and 240 reports, respectively. The age range for CIS reporting individuals is 12 to 95 years old. The number of reports received from healthcare professionals is 40, from 566 patients, while 130 reports were received from the Eudravigilance database.
“Two cases of myocarditis were reported in June after the Comirnaty and Moderna vaccines. It is true that they were arranged for the elderly. I will remind you that myocarditis is included in the summaries of the vaccine characteristics as extremely rare adverse reactions. (. ..) Last month we received reports about the reactions experienced by minors, some of them – severe, ”said G. Andrulionis.
As in previous months, the main reports of COCs in people vaccinated with COVID-19 who received IUDs were very similar: pain, swelling and redness at the injection site, arm pain, chills, headache, skin rash and fever. Most of these reactions were mild to moderate in severity and resolved after a few days.
The most common vaccine reactions
Analyzing the adverse reactions for each vaccine separately, Rugilė Pilvinienė, Senior Advisor to the ICD’s Pharmacovigilance and Poisoning Information Unit, indicated that a total of 1,800 adverse reactions had been reported to Comirnaty.
“I remind you that a report, a case can contain various side effects, such as headache, fever, general malaise, weakness. (…) So these numbers should not be intimidating.
After counting the 10 most frequently reported adverse reactions, we see that they are listed below. The most common side effects are fever and headache, followed by injection site pain, general weakness, and pain and chills in the hands. Rare side effects include fatigue, nausea, muscle aches, and lymphodenopathy, ”he said.
According to the specialist, lymphodenopathy is a lesion of the lymph nodes when it is near the injection site, usually in the armpit.
“There have been quite serious cases of enlarged lymph nodes. This is not surprising, because it is the lymphatic system that responds first to the appearance of a foreign protein in the body. (…) In this case, lymphodenopathies were reported more frequently elsewhere; there may be an enlarged lymph nodes in the neck, there have been cases of enlargement under the jaw. Previously, an increase in lymph nodes in the groin was also reported, ”explained R. Pilvinienė.
Adverse reactions to the Moderna vaccine are similar to those of the Comirnaty vaccine, which has a relatively low flow of reports.
The IWT specialist added that while Vaxevria generated a lot of controversy and a great flow of messages as soon as the vaccine was launched on the market a few months ago, vaccination coverage has now dropped significantly.
“Consequently, the flow of messages has decreased. (…) Once again, the predominant reactions are similar to other vaccines: fever, headache, chills and muscle aches,” he said.
Serious side effects
Speaking of serious adverse reactions, R. Pilvinienė noted that their total number is small.
“Comirnaty is the most commonly reported serious side effect. I would like to remind you that these vaccines have had the highest number of adverse reactions, and this shows a certain proportion, as the vaccine is the one that has been used the most, so they can be wait for more reactions.
According to her, although the link between thrombocytopenia and thrombotic syndrome caused by AstraZeneca and the association of thrombophlebitis as a separate AstraZeneca-specific adverse reaction with vaccination has been ruled out in recent months, such reports have been reported.
“We are still receiving another report of thrombophlebitis, two reports for Comirnaty and one for Vaxveria,” he said.
The IWT specialist also added that two cases of myocarditis were recorded, one of which was recorded last month after the Moderna vaccine.
“The only difference is that last month I received a report of myocarditis in a young person, this month we received reports of myocarditis in older people – in the case of” Moderna “I was over 50 years old. a woman and, in the case of Comirnaty, a man. We have no further data on the outcome of these cases, “said R. Pilvinienė.
As in previous months, two reports of peripheral facial paralysis have been reported since the vaccine was introduced to the market.
“Shingles has not been identified in clinical trials, but we are getting 1-2 such cases for the second month in a row. Probably the most common cause of serious side effects was fainting – people fainted after vaccination and vaccination in the center, and some faints were already at home, ”he said.
The largest number (6) of reports of this type were reported to the Comirnaty, and one case occurred in the 17-year-olds. for a young person. Rare serious reactions include acute inflammation of the eyes (uveitis) and toxic liver damage. Over 70 years, a person developed Evens syndrome.
One death was also reported after vaccination.
One death was also reported after the vaccine.
“It is noteworthy that the patient, who was reported in June, was vaccinated in March and died in April. This patient is a 91-year-old man who died in a medical facility. According to his relatives, he was diagnosed with pneumonia, ”said R. Pilvinienė.
“It seems to the relatives that the deterioration was due to vaccination. We cannot confirm or deny this case,” said the specialist.
1.2 million people received at least one vaccine
Last day, 278 people received the first dose of the coronavirus vaccine and 206 people received the second, according to Statistics from Lithuania on Monday.
In the country, COVID-19 has been vaccinated with at least one dose of 1 million vaccines. 277,415 people, both 1 million. 74,422.
At least one dose of the 54.5% vaccine was administered. population over 80 years old, 69.1 percent. – population between 75 and 79 years old, 71.5%. – 70-74 years and 70.1 percent. – population from 65 to 69 years old.
In the 55-64 age group, 58.8% are vaccinated, in the 45 to 54 age group – 52.5%, in the 35 to 44 age group – 50.9%, in the 25 age group at 34 years – 43.9 percent, 16 – in the group of 24 years – 42.1 percent. population. 9.7 percent of children ages 12 to 15 were vaccinated.
These values increased between 0.1 and 0.2 percentage points per day.
In Lithuania, 45.7% have received at least one coronavirus vaccine. people: 0.1 percentage points more than a day before.
In total, Lithuania has received 3 million. 98,155 doses of vaccines, of which 2 million were used. 351 thousand 837 doses.
Currently unused about 746 thousand. vaccine dose.
How do I report an adverse reaction?
The IWC reminds in which cases RNA reports should be made to a vaccine:
– when a link to the specific vaccine used is suspected,
– when the causal relationship between the IRR and the use of the medicine / vaccine is in doubt.
This should be reported by the healthcare professional or the patient.
The SCC also notes that healthcare professionals (doctors, nurses) have been informed of the suspected adverse reaction as soon as possible, but no later than 15 days after the suspected adverse reaction to the vaccine has occurred and / or received. , must submit a Suspected Adverse Reaction (ADR) form to ICD Healthcare or pharmacist. You can report:
– by filling in the form directly online https://vapris.vvkt.lt/vvkt-web/public/nrvSpecialist.
– by filling in the notification form for specialists (can be found at https://www.vvkt.lt/index.php?1399030386) and sending an email. by mail [email protected]
Users themselves can also record the side effects of vaccines. The notification can be sent in the following ways:
– filling in the form directly online https://vapris.vvkt.lt/vvkt-web/public/nrv;
– by filling in the patient notification form (can be found at https://www.vvkt.lt/index.php?4004286486) and sending it by email (at [email protected]);
– free phone 8800 73568.
When notifying a TIR, IWT does not need to provide your personal data, IWT only asks for contact information so that we can contact you if necessary. All data provided in the report is secure and confidential.
If a patient does not want to report CPR themselves, they can ask someone else, such as a healthcare professional or pharmacist, to do so. However, it is essential for IWT to know the age and sex of a person who has experienced CKD, as this information is important for investigating and evaluating the factors that may lead some patients to a particular CNS.
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