Thursday 2 February 2023

Less than 0.7% of people vaccinated against COVID-19 have had “some type of event”

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QCOSTARICA – On Friday, March 12, the Ministry of Health reported that, of the total number of people vaccinated against COVID-19, 0.67% have presented “some type of event” supposedly attributable to vaccination or immunization.

The majority of cases (73%) is in women and within the age range between 30 and 39 years.

From December 24, 2020, to February 28, 2021, with about 150,000 doses of vaccines applied in the said period, the National Center for Pharmacovigilance (CNFV) of the Ministry of Health received a total of 1,653 notifications of events supposedly attributable to the Vaccination and Immunization (ESAVI) with the Pfizer – BioNTech COVID-19 vaccine, of which 1608 of which have been analyzed.

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Xiomara Vega, coordinator of the National Center for Pharmacovigilance, stressed that “most of the notifications include several ESAVIs, for example, a person may have had pain at the injection site and fever after the administration of the vaccine.”

Nervous system disorders (mostly headache) have been the most reported events, followed by application site disorders (local pain), general disorders (fatigue/tiredness, fever / low-grade fever, chills), skin disorders and appendages such as skin rash and/or rash as well as itching and disorders of the musculoskeletal system.

An ESAVI was also received that meets the definition of an anaphylactic reaction (sudden and generalized allergic reaction), however, since it was admitted on February 26, 2021, and it is under investigation, it will be included in the March 2021 report, once the investigation is concluded.

Similarly, three Events of Special Interest (AESI) were reported:

  • A myocarditis (inflammation of the heart) classified as probable given the potential relationship between the symptom and vaccine administration.
  • A phlebitis (inflammation of the veins) which was classified as possible, since it may be due to other factors or drugs consumed by the patient.
  • A case of Guillain Barré syndrome was classified as conditional, due to the pathologies presented by the patient that could trigger the condition.

The patients who presented myocarditis and phlebitis have recovered, the patient who presented Guillain Barré is stable.

Since October, a work team has been formed in which the Epidemiological Sub-Surveillance Directorate and the Pharmaco-epidemiology Directorate of the Costa Rican Social Security Fund (CCSS) participate in conjunction with personnel from the Ministry of Health, who analyze the report of events allegedly attributable to vaccination against COVID-19.

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