
The San Jorge University Hospital signs an agreement with the IIS Aragón to promote research
September 21, 2021
"If aerosols had been talked about from the beginning, we might not be in a pandemic."
September 22, 2021The Spanish Agency for Medicines and Health Products has published the VIII Pharmacovigilance Report on vaccines against covid-19; updates information on reported cases of myocarditis/pericarditis, Guillain-Barré syndrome, capillary leak syndrome, or thrombosis with thrombocytopenia syndrome.
The walk of the immunization against covid-19 towards younger ages has been going at a good pace this summer, and Now users of nursing homes and people with immunodeficiency are beginning to be vaccinated with the third dose. In addition, with the start of the school year, the beginning of vaccination in children under 12 years of age is eagerly awaited.
The Spanish Agency for Medicines and Health Products (AEMPS) continues to analyze every available data and provide new relevant information on the safety of effective vaccines against the disease. Until September 5, 2021 (Spain had received 66.835.878 doses of vaccines) they were registered in Spain 41.751 reports of adverse events, of which 8.515 were considered serious and 300 had a fatal outcome. This represents 62 notifications for every 100.000 doses administered. 72% have been reported by health professionals and 28% by citizens; -he 88% in people between 18 and 65 years old, and 76% in women. The The most frequently reported events continue to be fever and pain in the vaccination area, headache and dizziness, myalgia and arthralgia. It should be noted that these events cannot be considered vaccine-related simply because they are reported.
In the country they have been inoculated As of September 20, a total of 69.332.829 doses, and there are 36.005.546 people who have the complete vaccination schedule. Since the beginning of the pandemic, 4.937.984 cases of covid have been confirmed and 85.983 have died, according to update number 467 of the Ministry of Health.
Side effects of covid vaccines reported in Spain until September 5, 2021
Among the different adverse reactions are those identified (myocarditis and pericarditis, capillary leak syndrome, immune thrombocytopenia, thrombosis syndrome with thrombocytopenia, Guillain-Barré syndrome and diarrhea) and those that remain under evaluation (menstrual disorders, erythema multiforme, multisystem inflammatory syndrome, cerebral venous sinus thrombosis without thrombocytopenia and glomerulonephritis and nephrotic syndrome).
Myocarditis and pericarditis in Pfizer and Moderna
The symptoms that may be associated with cases of myocarditis or pericarditis They are difficulty breathing, palpitations that may be accompanied by an irregular heartbeat, or chest pain. The European Pharmacovigilance Committee (PRAC) has stated that for now there is no new information that would change the current recommendations.
As of August 8, 2021, they have registered 98 cases of myocarditis and/or pericarditis after the administration of Pfizer in Spain. However, in most of them, patients were in recovery or had recovered at the time of notification. The cases occurred more in men (62%), after the second dose (56%) and in the first week after receiving the vaccine (70%). Two people died.
Until the same date, A total of 22 notifications were registered with Moderna, with more than 6 million doses administered. Most cases occurred in men (82%) and in the first week after receiving the vaccine (77%). All patients recovered or were recovering at the time of notification.
Menstrual disorders in Pfizer, Moderna, Janssen or AstraZeneca
The PRAC clarifies that A causal relationship has not been established with these menstrual disorders after vaccination. with Pfizer, Moderna or Janssen. The same thing happens with the AstraZeneca vaccine. where as of July 31, 2021, 12.410 cases were reported worldwide. The evaluation of these cases concludes that neither a common pattern nor a potential mechanism of action of the vaccine can be identified.
Erythema multiforme on Pfizer or Moderna
The PRAC is evaluating whether there is a relationship between receiving any of the mRNA-based vaccines (Pfizer and Moderna) and cases of erythema multiforme. This disorder is a acute skin reaction caused by an infection or other trigger and characterized by the appearance of rounded skin lesions, and which can also affect the mucous membranes in the internal cavities of the body. It resolves without the need for treatment. The reported cases are events that have been observed after vaccination, but do not mean that they are directly related to or caused by the vaccine.
Glomerulonephritis and nephrotic syndrome in Pfizer or Moderna
The evaluation of cases of glomerulonephritis (inflammation of the small filters in the kidneys) and nephrotic syndrome (a kidney disorder which causes them to leak too much protein into the urine), reported after receiving any of these vaccines. Symptoms include bloody or foamy urine, edema (swelling of the eyelids, feet, or abdomen), or fatigue.
Multisystem inflammatory syndrome (SIM) in Pfizer, Moderna, Janssen or AstraZeneca
Based on the notification of a case of SIM after vaccination with Pfizer in a 17-year-old male in Denmark, who recovered, the PRAC evaluates whether there is an increased risk of suffering from this syndrome with the vaccines. Other cases of SIM have been reported with this and the other vaccines and also in adults, within and outside the EEA.
This syndrome causes a serious inflammatory condition, which affects various parts of the body. Your symptoms may include tiredness, severe and persistent fever, diarrhea, vomiting, stomach pain, headache, chest pain and difficulty breathing. SIM occurs rarely, with an overall incidence rate of 0,51 cases per 100.000 patient-years.
Cerebral venous sinus thrombosis without thrombocytopenia on AstraZeneca
The PRAC is evaluating these cases that cause a rare stroke, in which the blood clot forms in the venous sinuses of the brain, without thrombocytopenia (that is, without having low levels of platelets in the blood), which have been reported after vaccination with Vaxzevria. Additional data has been requested from the TAC (Marketing Authorization Holders) for the next monthly report.
Capillary leak syndrome on AstraZeneca
Last June, this syndrome was identified as a possible adverse reaction to the AstraZeneca vaccine. Is about a very rare, but serious and life-threatening disorder, which causes extravasation of fluids from the blood capillaries to the outside. However, as of August 8, 2021, no cases have been reported in Spain.
The PRAC has evaluated different mechanistic hypotheses for the development of this syndrome after vaccination, without being able to identify a definitive mechanism. However, people who have previously had this syndrome are reminded not to be vaccinated with AstraZeneca. Additionally, people who experience rapid swelling of the arms and legs, sudden weight gain, and feeling faint (low blood pressure) in the days following vaccination should seek immediate medical attention.
Thrombocytopenia thrombosis syndrome (TTS) with AstraZeneca and Janssen
In May 2021, the information on this vaccine was included: risk (very rare) of thrombosis syndrome (formation of blood clots in blood vessels) with thrombocytopenia (low levels of platelets).
The latest analysis of reported cases includes 43% of cases in men and 37% in people over 60 years of age. As of July 31, 2021, 1.503 cases have been reported worldwide, with around 592 million doses of AstraZeneca having been administered as of July 25.
In Spain, until August 8, 31 cases suggestive or confirmed of TTS have been recorded, of which seven had a fatal outcome. Most thromboses occurred in unusual locations (venous sinuses or splanchnic veins). Of the 31 cases, 30 occurred after the first dose; Up to that date, nearly 9,6 million doses had been administered.
In Spain, until August 8, 2021, there have been registrations five confirmed or probable cases of TTS in people vaccinated with Janssen, with nearly 1,8 million doses administered. The thromboses occurred in unusual locations (cerebral thromboses or splanchnic veins); two of the patients died.
It is recommended for people who experience severe or persistent headache, seizures, blurred vision, chest pain, confusion, difficulty breathing, swelling or pain in the legs, persistent abdominal pain, or bruising or dot-like spots on the skin. small rounds, which are not located at the vaccination site, up to three weeks after the vaccine is administered, seek immediate medical attention.
Guillain-Barré Syndrome (GBS) with AstraZeneca and Janssen
This syndrome is a rare neurological condition. A rare immune system disorder that attacks the nerves of the peripheral nervous system that connect the brain and spinal cord to the rest of the body, causing inflammation and difficulty transmitting signals. In very severe cases it can progress to paralysis. Most patients recover from symptoms.
The PRAC has concluded that the SGB It is a possible adverse reaction of this vaccine, the frequency of which is very rare.. Patients diagnosed with this syndrome after receiving the first dose of the vaccine should consult their doctor before receiving a second dose.
As of July 31, 833 cases of GBS following vaccination have been reported worldwide, with around 592 million doses having been administered. In Spain, as of August 8, 2021, 32 confirmed cases of GBS had been recorded, none with a fatal outcome. Until that date, nearly 9,6 million doses had been administered.
Also the SGB has been included in the product information of the Janssen vaccine as a possible adverse reaction. Until June 30, 2021 108 cases of GBS have been reported worldwide, more than 21 million people having received this vaccine. One of the cases had a fatal outcome. In Spain, as of August 8, 2021, five confirmed cases of GBS have been reported, none of them with a fatal outcome. To date, nearly 1,8 million doses of this vaccine had been administered.
It is recommended to see a doctor urgently in case of weakness and paralysis in the extremities that can progress to the chest and face.
Venous thromboembolism without thrombocytopenia with Janssen
Data on cases of venous thromboembolism (blood clots in the veins) who have received the Janssen vaccine. Venous thromboembolism was included in the Risk Management Plan of this vaccine at the time of its authorization as a safety issue that needed to be investigated, since in clinical trials a higher proportion of cases was observed in the vaccinated group than in the unvaccinated group. The PRAC will evaluate additional data from two subsequent large clinical trials to determine whether this condition may be linked to the administration of this vaccine.
Immune thrombocytopenia with Janssen
Immune thrombocytopenia is a medical condition in which the immune system mistakenly attacks blood cells called platelets, which are necessary for normal blood clotting, and destroys them. Until June 18, 2021, there had been notifications 120 cases worldwide of suspected immune thrombocytopenia, 27 in clinical trials and 93 through vaccination campaigns; Of all of them, four had a fatal outcome. As of June 30, 2021, more than 21 million people have received this vaccine worldwide. In Spain, as of August 8, two cases have been recorded with nearly 1,8 million doses administered.