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

Amaro, Carina; Monteiro, Cristina; Duarte, Ana Paula

doi:10.3390/jcm11195591

Cited by 4 publications

(3 citation statements)

References 22 publications

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“…Our finding that the incidence of systemic reactions was higher following first dose ChAdOx1-S compared with BNT162b2 or CoronaVac, and that the incidence of systemic reactions was higher following second dose BNT162b2 compared with ChAdOx1-S or CoronaVac, are consistent with other studies. 18 , 23–25 Our study is the first to include a comparison with CoronaVac.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing adverse events following COVID-19 vaccination

Villanueva,

McDonald,

Croda

et al. 2024

Human Vaccines & Immunotherapeutics

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Various novel platform technologies have been used for the development of COVID-19 vaccines. In this nested cohort study among healthcare workers in Australia and Brazil who received three different COVID-19-specific vaccines, we (a) evaluated the incidence of adverse events following immunization (AEFI); (b) compared AEFI by vaccine type, dose and country; (c) identified factors influencing the incidence of AEFI; and (d) assessed the association between reactogenicity and vaccine anti-spike IgG antibody responses. Of 1302 participants who received homologous 2-dose regimens of ChAdOx1-S (Oxford-AstraZeneca), BNT162b2 (Pfizer-BioNTech) or CoronaVac (Sinovac), 1219 (94%) completed vaccine reaction questionnaires. Following the first vaccine dose, the incidence of any systemic reaction was higher in ChAdOx1-S recipients (374/806, 46%) compared with BNT162b2 (55/151, 36%; p = 0.02) or CoronaVac (26/262, 10%; p < 0.001) recipients. After the second vaccine dose, the incidence of any systemic reaction was higher in BNT162b2 recipients (66/151, 44%) compared with ChAdOx1-S (164/806, 20%; p < 0.001) or CoronaVac (23/262, 9%; p < 0.001) recipients. AEFI risk was higher in younger participants, females, participants in Australia, and varied by vaccine type and dose. Prior COVID-19 did not impact the risk of AEFI. Participants in Australia compared with Brazil reported a higher incidence of any local reaction (170/231, 74% vs 222/726, 31%, p < 0.001) and any systemic reaction (171/231, 74% vs 328/726, 45%, p < 0.001), regardless of vaccine type. Following a primary course of ChAdOx1-S or CoronaVac vaccination, participants who did not report AEFI seroconverted at a similar rate to those who reported local or systemic reactions. In conclusion, we found that the incidence of AEFI was influenced by participant age and COVID-19 vaccine type, and differed between participants in Australia and Brazil.

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Section: Discussionmentioning

confidence: 99%

Factors influencing adverse events following COVID-19 vaccination

Villanueva,

McDonald,

Croda

et al. 2024

Human Vaccines & Immunotherapeutics

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“…The impact of misinformation on trust in health institutions and vaccine programs during the pandemic underlines the importance of ongoing safety monitoring [ 22 ]. The significance of mechanisms such as the National Pharmacovigilance System (NPS) ensures the safety of the COVID-19 vaccine’s post-market introduction [ 23 ]. Additionally, it is important to evaluate vaccine safety and efficacy among diverse populations through the analysis of adverse events following immunization (AEFIs) [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

Hodel,

Fiuza,

Conceição

et al. 2024

Pharmaceuticals

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Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.

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“…A preparedness for future pandemic situations will most likely include a variety of measures of which some have been discussed by us and others [ 5 , 6 ]. However, to improve the efficacy of the present daily pharmacovigilance activity, the robotic process automation technique and additional measures to facilitate the submitting of ADRs should be implemented immediately.…”

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confidence: 99%