Spain has confirmed, until September 5, a total of 41,751 notifications of adverse events after the administration of 66,835,878 doses of vaccines against COVID-19, which would correspond to 62 notifications per 100,000 doses administered.
Of these, 8,515 were considered serious and 300 presented a deadly outcome.
This is reflected by the 8th Pharmacovigilance Report on Vaccines Covid-19, published on Thursday by the Spanish Agency for Medicines and Health Products (AEMPS), which insisted that these events “can not be considered related to vaccines by mere fact of notification
“.
In fact, in the “great majority” of the cases notified in Spain, the death “can be explained” by the “previous” clinical situation of the patient and / or by other treatments that were taking and the causes “are diverse without presenting a
Homogeneous pattern, “according to the agency.
In general, most notifications correspond to people between 18 and 65 years (88%) and mostly women (76%) and the most frequently notified events continue to be general disorders (fever and pain in the vaccination zone)
, from the nervous system (headache and dizziness) and the musculoskeletal system (myalgia and arthralgia).
As regards the Pfizer vaccine, a total of 23,301 notifications of adverse events have been recorded, most of which correspond to women (77%) and people between 18 and 65 years (84%) and, of them
, 4,709 were considered serious.
With regard to cases of myocarditis and pericarditis, which were recently included in the technical sheet and the Pfizer prospectus as possible adverse reactions to the vaccine, until August 8, 98 notifications have been registered after administration in Spain.
Most cases occurred in men (62%), after the second dose (56%) and in the first week after receiving vaccine (70%) and in two cases notified, patients died.
As regards the multiform erythema, a hypersensitivity reaction (allergic) characterized by the appearance of rounded skin lesions and can also affect mucous membranes in the agency’s internal cavities, the EMA has begun the evaluation of this
Signal to establish if an adverse reaction associated with any of MRNA-based vaccines as a result of notification of some cases.
Likewise, the evaluation of the cases of glomerulonephritis (inflammation of the small filters that exist in the kidneys) and nephrotic syndrome (kidney disorder that causes these filtering too much amount of protein to urine), notified in subjects who had received
Some of the Vaccines based on mRNA.
The beginning of this evaluation has been motivated by the publication of a “small” number of cases, including some in which patients had “relapses” of pre-existing kidney diseases, according to the AEMP.
As regards the multisystemic inflammatory syndrome (SIM), a serious inflammatory condition that affects several parts of the agency and that has been associated with COVID-19 itself, EMA is evaluating if there is an “increased” risk of suffering this syndrome
With vaccines against COVID-19 after notification of several cases inside and outside the European Economic Area (EEA).
As for the modern vaccine, there are also possible cases of menstrual disorders, multiform erythema, glomerulonephritis and nephrotic syndrome, as well as multisystemic inflammatory syndrome after registering a total of 6,332 notifications of adverse events, most corresponding to women (
78%) and people between 18 and 65 years (90%) and 983 of which were considered serious.
In Spain, a total of 22 notifications of myocarditis and pericarditis have been registered until the administration of this vaccine and most cases occurred in men (82%) and in the first week after receiving the vaccine (
77%).
As regards AstraZeneca, up to 5 September there were a total of 10,949 notifications of adverse events after administration;
The majority corresponded to women (73%) and people between 18 and 65 years (95%) and, of the total, 2,512 were considered serious.
The AEMPS recalled that the notified cases of menstrual disorders have already been reviewed after their administration and that until July 31, 12,410 cases were notified throughout the world in the context of around 592 million doses administered until 25;
July.
The evaluation of these cases could not identify a common pattern or a “potential” mechanism of action of the vaccine and EMA has concluded that there is no evidence to suggest a causal relationship between notified menstrual disorders and the administration of this vaccine.
Among the adverse reactions already identified highlights the capillary leakage syndrome, a very rare, but severe and potentially fatal disorder, which causes extravasation of fluids from the blood capillaries to the outside.
Until August 8, 2021, no case has been notified in Spain.
In addition, it continues to “closely monitored” thrombosis syndrome with thrombocytopenia (STT) with the purpose of characterizing possible risk factors and, until August 8, 31 cases “suggestive” or confirmed, of which seven have been recorded in the country.
They had deadly outcome and 30 occurred after the first dose.
Most thrombosis were presented in unusual locations (venous sinuses or splanch veins).
Regarding Guillain-Barré syndrome (SGB), a very rare immune system disorder that causes inflammation of peripheral nerves and may result in pain and / or numbness, initially of extremities, muscle weakness and difficulty for wandering and
, In very severe cases, paralysis, until August 8, 32 confirmed cases had been registered in Spain, none with deadly outcome.
Next to this, cases of multisystemic inflammatory syndrome are also evaluated, as well as brain venous sinus thrombosis (one form of rare stroke in which the blood clot is formed in the venous sinuses of the brain) without thrombocytopenia (ie,
Without having low levels of platelets in blood).
Finally, as regards Janssen, 1,106 notifications of adverse events have been confirmed after its administration, the majority corresponded to women (58%) and people between 18 and 65 years (86%) and 288 were considered serious.
Possible effects such as menstrual disorders, multisystem inflammatory syndrome and venous thromboembolism (blood clots in the veins) are in evaluation.
Regarding adverse reactions identified, AEMPS highlights immune thrombocytopenia, a medical condition in which the immune system attacks blood cells called platelets and destroys them.
In Spain, until August 8, two cases have been recorded.
Likewise, the report refers to thrombosis syndrome with thrombocytopenia and warns that, until August 8, in Spain, five cases, confirmed or probable, have been recorded in people vaccinated with Janssen and that thrombosis were presented in unusual locations (
Brain thrombosis or splanchnic veins) and two of the patients died.
As for Guillain-Barré syndrome, until August 8, five confirmed cases have been reported, none of them with deadly outcome.
Likewise, it is added as possible adverse reactions to this vaccine in the technical sheet and leaflet Lymphadeneopathies (inflammation of the lymphatic nodules), paresthesias (non-habitual sensation in the skin, such as tingling or chills) and hypoesthesias (numbness or decreased sensitivity
, mainly on the skin), Tinnitus (persistent rings in the ear), diarrhea and vomiting and dizziness.
