The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H) has received 84 reports of adverse events after the puncture among the almost 121,000 people vaccinated with AstraZeneca, the last vaccine to be authorized for the prevention of Covid-19 in Spain.
The 84 notifications include 267 descriptive terms of adverse events. General disorders such as fever or pain in the vaccination area they have been the most frequently reported, followed by disorders of the nervous system (mostly headaches and dizziness) and of the musculoskeletal system (arthralgia and myalgia).
This is stated in the third update of the Pharmacovigilance Report on Covid-19 Vaccines, carried out with data up to February 21 and which underlines that an adverse event “is any health problems that occur after vaccination without necessarily having to be caused by the vaccine ”, since it may be medical problems that coincide in time or that are related to the act of vaccination itself.
Since it was licensed, the AstraZeneca vaccine has faced the stigma of causing more side effects than the rest, information that denies the report. In the global computation, 205 reports of adverse effects per 100,000 doses administered.
If separated by type of vaccine, the Pfizer-BioNTech vaccine would have registered 204 reports per 100,000 doses administered, Moderna 332 reports per 100,000 doses administered and AstraZeneca 69 reports per 100,000 doses administered.
The data offered by this system coordinated by the Spanish Agency for Medicines and Health Products (AEMPS) includes notifications of adverse events occurring after vaccination “and adverse reactions due to the vaccine cannot be considered“.
Under these premises, the report highlights that, until that day, 3,058,776 doses of vaccines had been administered against Covid-19, corresponding to 1,860,403 people, as 64% completed the two-puncture schedule.
In this period, a total of 6,266 notifications of adverse events have been registered in the FEDRA database, which would correspond to 205 reports per 100,000 doses administered.
89% have been reported by health professionals, and 11% through the form addressed to citizens. Most of the notifications from health professionals have been made by medical (46%) or nursing (30%) personnel.
Most of the notifications correspond to women (83%) and to people between 18 and 64 years old (91%). Two cases have been reported in infants whose mothers had been vaccinated with Covid-19 Vaccine Moderna and Comirnaty.
The vast majority, 92%, were from Comirnaty (Pfizer / BioNtech), 4% from Moderna and 4% from AstraZeneca; by ages, 75% of those immunized have been people between 18 and 64 years old and 25%, over 65 years of age.
Only 0.002% have suffered effects after receiving the punctureAccording to the report: from December 27 to February 21, a total of 6,266 notifications of adverse events have been recorded, which would correspond to 205 per 100,000 doses administered. There are two cases in infants whose mothers had been vaccinated with Moderna and Pfizer.
However, it cautions that these notifications cannot be used as a tool to calculate the frequency of occurrence of adverse reactions in vaccinated people. nor does it serve “to make comparisons on the safety of different vaccines”.
The Pfizer Vaccine
A total of 2,808,344 doses of Cominarty have been administered to 1,631,448 people (1,176,896 received the second), mostly women (72%) and, according to their age, 72% correspond to people between 18 and 64 years old and 28% to people over 65 years old.
5,736 reports of adverse events have been registered, corresponding to 204 reports per 100,000 doses administered, 0.2% of the total.
These 5,736 notifications include 15,387 descriptive terms for these adverse events: general disorders such as fever or pain in the vaccination area they are still the most frequent, followed by those of the nervous system (especially headaches and dizziness) and of the musculoskeletal system (mainly myalgia and arthralgia).
In this way, the fever accounts for 39% of the effects, headache 29%, myalgia 20% and pain in the area of the puncture, 13%. In any case, they are “temporary events that may appear in the first days after vaccination.”
The cases of anaphylaxis are the same 8 as reflected in the previous update, with a rate that oscillates between 5-10 per million administered doses.
The doses of this vaccine injected until February 21 amount to 129,602, corresponding to 108,143 people, since 21,459 completed the pattern; the majority were women (73%) and, by age group, 97% were between 18 and 64 years old and 3% were older than 65 years.
In this period, there have been 430 reports of adverse events after administration, which would correspond to 332 reports per 100,000 doses administered (0.33%), which include 1,254 descriptor terms.
Like the rest, they are also the general disorders such as fever or pain in the vaccination area the most reported, followed by disorders of the nervous system and the musculoskeletal system.
The most common is fever (42%), along with headache (28%) and myalgia (17%).
Anaphylaxis is also a known adverse reaction for this vaccine, but at this time “it is not possible to calculate your notified rate in Spain with some reliability, due to the limited number of doses administered until February 21, 2021 ″.
The AstraZeneca vaccine
Until that day they have been inoculated 120,830 first doses of AstraZeneca, since the second is injected between 10 and 12 weeks after the first; the majority of people vaccinated with this preparation have been women (67%) and all aged between 18 and 64 years.
In this case, 84 reports of adverse events, which is equivalent to 69 notifications per 100,000 doses administered (0.05%), and includes 267 descriptive terms of adverse events.
The most common effects are fever (82%); headache (51%); myalgia (31%) and pain in the vaccination area (21%).
“All of them, except asthenia (nonspecific symptom that accompanies other events), constitute known adverse reactions for this vaccine and, therefore, are already included in its technical data sheet and package leaflet. They are temporary reactions that can occur in the first days after vaccination ”, highlights the document.