Spain reports 71 adverse effects for every 100,000 doses of vaccines administered

24/11/2021 – 17:08 Updated: 11/24/2021 – 5:13 PM

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The Spanish Pharmacovigilance System of Medicines of Human Use has received until last November 14 50,824 reports of adverse events after the administration of almost 72 million doses of vaccines – which is equivalent to 71 per 100,000– and only one in five were serious.

This is stated in the 10th Report Pharmacovigilance on Vaccines covid-19, published this Wednesday by the Spanish Agency for Medicines and Health Products (AEMPS), which coordinates this system integrated by the regional pharmacovigilance centers.

An adverse event is any problem of Health that occur after vaccination, without being considered to be caused by it: they can be simply coincident in time, related to the act of being vaccinated (anxiety, fainting, error in administration), related to a potential problem of drug quality or really linked to it, as are the pain in the injection site or fever.

Under this premise, the data show that, until November 14, with 71,746,002 doses administered -71% of Pfizer, 13% from AstraZeneca, 13% from Moderna and 3% from Janssen- to a total of 38,329,299 people, the system has collectedor 50,824 notifications of this type of event. 71% have been reported by health professionals and 29% by citizens and the majority correspond to women (74%) and people between 18 and 65 years of age (87%).

Of these, 10,091 were considered serious, being understood as such any adverse event that requires or prolongs hospitalization, causes disability significant or persistent or a congenital malformationlife threatening or fatal, as well as any other condition that is considered clinically significant.

And, of the serious ones, 346 had a fatal outcome, although the Aemps clarifies that in the vast majority of notified cases that contain information on medical history and concomitant medication, the death can be explained by the previous clinical situation of the patient and / or other treatments that he was taking; the causes of death are diverse, without having presented a homogeneous pattern.

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In addition, it must be remembered that vaccination does not reduce deaths due to causes other than covid and during the campaign there will continue to be deaths, “sometimes in close temporal association with the administration of the vaccine, without this being related to the fact of having been vaccinated“.

In this tenth report, the Medicines Agency updates the list of adverse effects, in such a way as to rule out, according to the available evidence, the link of none of the vaccines with multisystemic inflammatory syndrome and, as it did with the other three, also rejects menstrual disorders in that of Janssen.

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Yes it has been identified as a possible adverse reaction of the Vaxzevria vaccine (AstraZeneca), cerebral venous sinus thrombosis without thrombocytopenia, of which in Spain there have been 20 cases after injection. For vaccines, Pfizer’s has resulted in 28,967 reports of adverse events after the administration of more than 51 million doses.

Of them, 221 have been myocarditis and / or pericarditis; most of these patients were in recovery or had recovered at the time of notification and generally occurred in men (71%), after the second dose (61%) and in the first week after receiving the vaccine (62%), being more frequent in young ages, with an estimated rate of 0.8 cases per 100,000 doses administered in under 40 years old.

Three patients had a fatal outcome; two of them, older than 60 years, presented alternative causes for the appearance of myocarditis

Three patients attended fatal outcome; two of them, older than 60 years, presented alternative causes for the occurrence of myocarditis, while the third party, also an adult, has limited information to carry out a correct evaluation about its possible relationship to the vaccine.

In Moderna’s case, reported adverse events amounted to 8,352 in 9,166,782 doses. This vaccine is also associated with myocarditis and / or pericarditis, which have been mentioned in 79 notifications, mostly men (90%), after the second dose (65%) and in the first week after the prick (78%). The reported rate is estimated at 1.4 cases per 100,000 doses administered in under 40 years old.

Of the 9,789,955 doses of Vaxzevria administered, 12,061 notifications, of which 2,710 were considered serious. Finally, in vaccinated Janssen people, of which 1,976,296 doses have been punctured, they have been counted 1,370 notifications after inoculation.

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