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. 2022 Sep 23;11(19):5591.
doi: 10.3390/jcm11195591.

COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal

Carina Amaro  1 , Cristina Monteiro  2 , Ana Paula Duarte  2   3
Affiliations

COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal

Carina Amaro et al. J Clin Med. .

Abstract

Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty®, Spikevax®, Vaxzevria® and Jcovden®. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.

Keywords: COVID-19 vaccines; adverse drug reactions; immunization; mRNA vaccines; pharmacovigilance; safety; vaccines with a viral vector.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Characterization of notifications by type of notifier.
Figure 2
Figure 2
Characterization of notifications by District of Origin of notification.
Figure 3
Figure 3
Characterization of notifications according to Gender.
Figure 4
Figure 4
Characterization of notifications according to the type of vaccine.
Figure 5
Figure 5
Characterization of notifications according to the brand name of the vaccine.
Figure 6
Figure 6
Characterization of Adverse Drug Reactions according to the description in the SmPC.
Figure 7
Figure 7
Study of Causality.
Figure 8
Figure 8
Characterization of notifications according to seriousness.
Figure 9
Figure 9
Characterization of serious notifications according to the brand name of the vaccine administered.
Figure 10
Figure 10
Characterization of serious notifications according to the seriousness criteria.
Figure 11
Figure 11
Characterization of serious notifications with the seriousness criteria “Hospitalization”, according to the brand of vaccine administered.
Figure 12
Figure 12
Characterization of serious notifications with the seriousness criteria “Life Risk”, according to the brand of vaccine administered.
Figure 13
Figure 13
Characterization of serious notifications with the seriousness criteria “Death”, according to the brand of vaccine administered.
See this image and copyright information in PMC

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