RESUMO
BACKGROUND: The effect of a preexisting comorbidity on the occurrence of adverse events after immunization (AEFIs) has been studied poorly. In this longitudinal cohort study, we assess the association between co-morbidities and the occurrence of AEFIs after COVID-19 vaccination. Also, we described the occurrence of flare-ups and their manifestation after COVID-19 vaccination in people with rheumatic diseases. RESEARCH DESIGN AND METHODS: We performed multivariable logistic regression to investigate the association between the occurrence of AEFIs and 10 common comorbidities using patient-reported data from people vaccinated with the AstraZeneca, Johnson&Johnson, Moderna, or Pfizer vaccine. RESULTS: Occurrence of any AEFI, injection site reactions, headache, fatigue, and/or malaise was significantly associated with presence of comorbidities, including psychological disorders, musculoskeletal disorders, and endocrine disorders after the first and second doses (OR ranges 1.23-1.77). One participant with rheumatoid arthritis experienced a flare-up after receiving the first dose of the AstraZeneca vaccine. DISCUSSION/CONCLUSION: The results showed that the odds of reporting an AEFI after COVID-19 vaccination is significantly higher in the presence of some comorbidities whilst flare-ups are uncommon after receiving COVID-19 vaccination in people with rheumatic disease. In-depth research is needed to validate our results and unravel the observed associations from a mechanistic perspective.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Estudos Longitudinais , Vacinas contra COVID-19/efeitos adversos , Países Baixos/epidemiologia , Estudos Prospectivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinação/efeitos adversos , Comorbidade , Medidas de Resultados Relatados pelo Paciente , MorbidadeRESUMO
INTRODUCTION: The annual reformulation of the seasonal influenza vaccine results in fluctuating frequencies and severity of adverse effects following immunization (AEFIs), which stresses the importance of pharmacovigilance. Also, sex-related factors are known to influence the development of AEFIs. This study aims to describe the difference in incidence and course (i.e., time-to-onset, time-to-recovery, and perceived burden) of AEFIs between males and females after seasonal influenza vaccination. METHODS: We assessed data from cohort event monitoring studies, which were performed over nine consecutive years (2013-2021), each covering several months during the seasonal influenza campaign in the Netherlands. Participants reported information about AEFIs over a 30-day period in three questionnaires. The effect of sex, age, body mass index, study year, and comorbidities on the incidence of any AEFI, local reactions, fever and the five most reported AEFIs was analyzed using logistic regression. The difference in time-to-onset, time-to-recovery, and perceived burden between males and females was analyzed by the Kruskal-Wallis test. RESULTS: The cohort included 7789 participants (53.0% females). Females had around 2.5-fold (p < 0.001) higher odds of developing any AEFI compared with males. Some study years and comorbidities were positively associated with AEFI incidence, whereas age was negatively associated. An AEFI had a significant shorter time-to-onset, a longer time-to-recovery, and a higher perceived burden in females compared to males. CONCLUSION: Overall, the results confirm that females experience AEFIs more often than males. Additionally, this study shows that the course of AEFIs only partially differs between the sexes.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacinas contra Influenza , Influenza Humana , Masculino , Feminino , Humanos , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Incidência , Países Baixos/epidemiologia , Estações do Ano , Vacinação/efeitos adversos , Vacinas contra Influenza/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Sistemas de Notificação de Reações Adversas a MedicamentosRESUMO
- More evidence has become available concerning the sexual transmission of Zika virus and viral shedding in semen, which has led to the expansion of international guidelines for prevention of sexual transmission; Dutch guidelines have not been altered.- Internationally, the use of condoms during sex or sexual abstinence is advised for the duration of the pregnancy. Furthermore, when actively trying to conceive one should use a condom for six months.- In the Dutch guidelines, men who have visited a Zika virus epidemic area are advised to use a condom for 2 months upon return, irrespective of their partner possibly being pregnant or their wish to conceive.- Based on reports to the World Health Organisation and patient reports, the serial interval between disease onsets of both sexual partners is 4-44 days (median: 15).- Zika virus RNA is often no longer detectable in semen 2-3 months after disease onset.- International guidelines are based on the maximum detection period of Zika virus RNA and on virus isolation. Dutch prevention guidelines, on the other hand, are based on the longest serial interval known for sexual transmission (44 days).- Detection of Zika virus RNA in semen does not give a definitive answer on contagiousness. Currently, following the Dutch prevention advice is the best option in order to prevent sexual transmission.