Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy

Scavone, Cristina; Mauro, Cristina Di; Brusco, Simona; Bertini, Michele; Mauro, Gabriella di; Rafaniello, Concetta; Sportiello, Liberata; Rossi, Francesco; Capuano, Annalisa

doi:10.1080/14740338.2019.1598969

Cited by 14 publications

(6 citation statements)

References 37 publications

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“…Similar findings were also reported from electronic health information system in the Canadian province of Ontario [30]. Findings from surveillance system of adverse vaccinal events in Southern Italy supported no rare or unexpected vaccine-related health problems [31]. Moreover, a study in the Netherlands examined short (3-6 months) and long-term (more than 6 months) fatigue as a result of HPV vaccination and reported absence of this association [32].…”

Section: Discussionsupporting

confidence: 72%

Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

et al. 2020

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Background: Previous studies have not explored the effect of HPV vaccination on health status at longer time interval. Similarly, self-reported physical and mental health in recipients of HPV vaccine has not been studied.Objective: To evaluate whether HPV vaccination was associated with physical and mental health complaints among girls in secondary education institutions. Design: Prospective cohort study.Participants: This study used data from girls aged 15-20 years who participated in the Danish National Youth Study (DNYS) 2014. Data on HPV vaccination was retrieved from the Danish Vaccination Register. Main Measures:Participants were asked whether they had experienced headaches, stomachache, neck pain, menstrual cramps, sore throat, sadness, irritation, nervousness and sleep problems in the past six months. Key results:Of 41,333 girls, 39,145 (94.7%) received at least one dose of HPV vaccine. The most prevalent health complaint among vaccinated and not vaccinated females was "been irritable" (88.2% and 88.4%, respectively). The lowest proportion of health complaints was stomachache (49.6% in vaccinated and in 50.4% in unvaccinated girls). Regression model, adjusted for sociodemographic characteristics and health behavior, showed that HPV vaccination was associated with lower likelihood of reporting sore throat (odd ratio [OR] 0.86, 95% confidence interval [CI] 0.78-0.95) and being sad (OR 0.86, 95%CI 0.76-0.97). Similar results were observed when HPV vaccination status was analyzed according to number of doses received. Conclusion:We conclude that HPV vaccination was not associated with physical and mental health complaints among girls in secondary education institutions in Denmark after a median of 5.3 years since HPV vaccination.

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Section: Discussionsupporting

confidence: 72%

Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

et al. 2020

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“…The 94.31% of ICSRs were reported by HCPs in accordance with other studies [ 27 , 28 , 29 , 30 , 31 ]. In most ICSRs was reported one suspected drug and no concomitant drugs.…”

Section: Discussionsupporting

confidence: 90%

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

et al. 2022

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Dapagliflozin was associated with an increased risk of diabetic ketoacidosis that has led to the European withdrawal of the authorization for the type 1 diabetes. However, it is still used for the treatment of type 2 diabetes. Therefore, we aim to evaluate the occurrence of dapagliflozin-induced ketoacidosis events by using the European spontaneous reporting system. The reporting odds ratios (ROR) were computed to assess the reporting frequency of ketoacidosis events for dapagliflozin compared to Dipeptidyl peptidase-4 (DPP-4) inhibitors, insulins, or all other Sodium-glucose cotransporter-2 (SGLT-2) inhibitors. A total of 2406 cases with dapagliflozin reported at least one event of ketoacidosis. The three most reported events were: diabetic ketoacidosis (1412; 55.39%), ketoacidosis (476; 18.67%), and euglycaemic diabetic ketoacidosis (296; 11.61%). Dapagliflozin was associated with the higher reporting frequency of ketoacidosis events compared to DPP-4 inhibitors (ROR 12.07, 95%CI 11.67–13.81) or insulins (ROR 7.59, 95%CI 7.13–7.89). A lower reporting frequency was instead observed compared to other SGLT2 inhibitors (ROR 0.91, 95%CI 0.87–0.96). Considering the higher reporting frequency of ketoacidosis observed with dapagliflozin then DPP-4 inhibitors or insulins, attention should be given to patients treated with this drug.

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“…The higher rate of ICSRs reported by HCPs matches with that of the results from other studies that have analysed ICSRs from national spontaneous reporting systems or from the EV [ 20 , 21 , 22 , 23 , 24 , 25 , 26 ].…”

Section: Discussionsupporting

confidence: 85%

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Velișcu,

Liguori,

Anatriello

et al. 2023

Pharmaceuticals

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Background. Cladribine belongs to the group of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). According to the highlights of a meeting held by the Pharmacovigilance Risk Assessment Committee (PRAC) on 14 January 2022, cladribine may be associated with the occurrence of liver injury, and thus liver function monitoring is recommended. Objectives and methods. Using data from the European spontaneous reporting database (EudraVigilance-EV), we aimed to describe the main characteristics of Individual Case Safety Reports (ICSRs) reporting cases of hepatobiliary disorders related to cladribine. The reporting odds ratio (ROR) was calculated to provide the probability of reporting hepatobiliary ICSRs among DMTs used to treat MS. Results. Overall, 118 ICSRs described the occurrence of cladribine-induced hepatobiliary ADRs. The majority of the ICSRs reported ADRs that were classified as serious (93%), and the outcome was mostly reported as “unknown” (50.8%). The most reported hepatobiliary disorders were drug-induced liver injury, abnormal hepatic function, ALT increases, liver disorders, hepatic failure, jaundice, lymphocyte count decreases, hepatotoxicity and hypertransaminasemia. The majority of cladribine-induced hepatic ADRs occurred in female patients belonging to the age group of 18–65 years. Conclusion. Considering the seriousness of cladribine-induced hepatic ADRs, a close monitoring of patients receiving this drug is highly recommended. In this context, further pharmacovigilance studies evaluating the hepatic safety profile of cladribine are strongly needed.

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Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy

Cited by 14 publications

References 37 publications

Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

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