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The side effects of the third dose of the most common Pfizer and Moderna vaccines

The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centers and coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), continuously assesses suspicions of Adverse reactions reported in Spain with all authorized medicines, including vaccines, and especially those applied against the coronavirus.

From the beginning of the vaccination campaign, until May 8, 2022 101,369,478 doses of vaccines against COVID-19 have been administered in Spaincorresponding to a total of 41,190,416 people.

  • 65% of the administered doses corresponded to Comirnaty (Pfizer vaccine).
  • 23% to Spikevax (Modern’s vaccine).
  • 10% to Vaxzevria (AstraZeneca’s vaccine).
  • 2% to Jcovden (the Janssen vaccine).

Of the total number of people vaccinated, 51% are women. Regarding the distribution by age groups, 67% correspond to people between 18 and 65 years old, 21% to people over 65 years old, 7% to people between 12 and 17 years old and 5% to children under 12 years old.

The most common reactions

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Adverse effects of the Pfizer vaccine.
AEMPS

Of the 70,965 notifications of citizens who have reported adverse reactions12,960 were considered seriousmeaning those that require hospitalization, have resulted in significant or persistent disability or congenital malformation, have been life-threatening or fatal, and any other condition that is considered clinically significant.

Of the 12,960 notifications of adverse events considered serious received until May 8, 434 died. These events cannot be considered vaccine-related simply by being reported.. In the vast majority of cases, death can be explained by the previous clinical situation of the patient and by other treatments that he was taking and the causes of death are diverse, without presenting a homogeneous pattern.

Vaccination does not reduce deaths from causes other than COVID-19so that during the vaccination campaign it is expected that deaths for other reasons will continue to occur, sometimes in close temporal association with the administration of the vaccine, without this being related to the fact of having been vaccinated.

Keep in mind that many of the observed diseases would appear in the same way if the person had not received the vaccine. Therefore, this information must be carefully analyzed to differentiate medical problems that could be a new adverse reaction to the vaccine from those that would still have occurred, even if the person had not been vaccinated.

The most common disorders

Of all adverse event reports identified, 608 were considered serious. General disorders like fever or malaise are the most frequently reported, followed by nervous system disorders (mainly headaches and dizziness) and the musculoskeletal system (myalgia and arthralgia).

The ten most notified ‘problems’, as well as their percentage with respect to the total number of notifications identified for the third dose (a notification may contain more than one adverse event). All, except malaise (a symptom that could be caused by other events such as fever), constitute known adverse reactions for this vaccine and are already included in its technical data sheet and package insert; the vast majority are transient reactions that can occur in the first days after administration of the vaccine.

Among them, pyrexia (35%), headache (18%), lymphadonopathy (15), myalgia (13%), malaise (12%), fatigue (9%), chills (8%), pain in the area vaccination (8%), nausea (7%), arthralgia (7%).

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