Objectives This study aimed to monitor use of COVID-19 vaccines and incidence rates of pre-specified adverse events of special interest (AESI) of COVID-19 vaccines prior to and after COVID-19 vaccination. This study was not aimed to test a specific hypothesis. Design A retrospective cohort study including subjects from January 1, 2020 to October 31st, 2021, or latest availability of data. Setting Primary and/or secondary health care data from four European countries: Italy, the Netherlands, the United Kingdom, Spain Participants Individuals with complete data for the year preceding enrolment or those born at the start of observation time. The cohort comprised 25,720,158 subjects. Interventions First and second dose of Pfizer, AstraZeneca, Moderna, or Janssen COVID-19 vaccine. Main outcome measures 29 adverse events of special interest (AESI): acute aseptic arthritis, acute coronary artery disease, acute disseminated encephalomyelitis (ADEM), acute kidney injury, acute liver injury, acute respiratory distress syndrome, anaphylaxis, anosmia or ageusia, arrhythmia, Bells palsy, chilblain-like lesions death, erythema multiforme, Guillain Barre Syndrome (GBS), generalized convulsion, haemorrhagic stroke, heart failure, ischemic stroke, meningoencephalitis, microangiopathy, multisystem inflammatory syndrome, myo/pericarditis, myocarditis, narcolepsy, single organ cutaneous vasculitis (SOCV), stress cardiomyopathy, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTS) venous thromboembolism (VTE) Results 12,117,458 individuals received at least a first dose of COVID-19 vaccine: 54% with Comirnaty (Pfizer), 6% Spikevax (Moderna), 38% Vaxzevria (AstraZeneca) and 2% Janssen Covid-19 vaccine. AESI were very rare: less than 10/100,000 PY in 2020, only thrombotic and cardiac events were uncommon. After adjustment for factors associated with severe COVID, 10 statistically significant associations of pooled incidence rate ratios remained based on dose 1 and 2 combined. These comprised anaphylaxis after AstraZeneca vaccine, TTS after both AstraZeneca and Janssen vaccine, erythema multiforme after Moderna, GBS after Janssen vaccine, SOCV after Janssen vaccine, thrombocytopenia after Janssen and Moderna vaccine and VTE after Moderna and Pfizer vaccines. The pooled rate ratio was more than two-fold increased only for TTS, SOCV and thrombocytopenia. Conclusion We showed associations with several AESI, which remained after adjustment for factors that determined vaccine roll out. Hypotheses testing studies are required to establish causality.
Background Tramadol, a weak opioid, inhibits the reuptake of serotonin, a key feature on vascular homeostasis. A suspected interaction exists between dabigatran and tramadol, which might trigger an excess on risk of bleeding however, there is a gap in knowledge on this topic. Purpose To estimate the effects of tramadol, dabigatran and concomitant use on the risk of hospitalized major bleeds (Gastrointestinal bleeding and intra‐extracranial bleeds). Methods Among a validated established cohort of new users of oral anticoagulants for non‐valvular atrial fibrillation (NVAF) aged 18 years or older, we identified all hospitalized bleed episodes (GIB and extra/intracranial bleeds) within 2008–2015. A nested case–control analysis was conducted using conditional logistic regression. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated for dabigatran, tramadol, and concomitant use. Several sensitivity analyses were carried out. Results aORs (95%CIs) for current use of only dabigatran, only tramadol and concomitant users were 1.73 (1.37–2.18) and 1.38 (1.13–1.67) and 2.04 (0.74–5.67) compared with non‐users of both drugs (>365 days). aORs for current continuers and non‐continuer users of dabigatran were 1.36 (1.00–1.86) and 2.19 (1.61–2.98), respectively. For the latter, non‐continuer users with a short duration of dabigatran cumulated the highest risk (3.36 [1.88–5.99]). There also was an increased risk with concomitant use of tramadol and rivaroxaban (2.24 [1.19–4.21]), or antagonist of vitamin K (1.30 [1.00–1.69]). Conclusion There was a trend towards and increased risk of excess bleeds when using concomitantly with dabigatran. The effect decreases with a narrower definition of current use.
Purpose This study aims to validate major bleeding (MB) cases within a cohort of new users of direct oral anticoagulants (DOACs) in Electronic health records (EHRs) from primary care in Spain (BIFAP), introducing more efficient techniques and automating the process of validation in the pharmacoepidemiologic research with EHR data as much as possible. Methods Registered bleedings were identified in a cohort of new users of DOACs in BIFAP using ICPC 2 and ICD 9 codes; we ascertained these bleedings as MB through a validation strategy based on the MB definition from the International Society on Thrombosis and Hemostasis, which used hospitalization and critical localization as proxies. We assessed hospitalization with hospital discharge information (only available for some years and regions) and a free text‐based algorithm created to identify hospitalization in EHR's clinical notes. Incidence rates (IR) of MB were evaluated by bleeding type. Results The study cohort included 104 614 patients, with 274521.5 p‐y of follow up. There were 6143 registered bleedings during the study period (519 intracranial bleeding – ICB, 4606 gastrointestinal bleeding – GIB, 1018 extracranial bleeding – ECB), from which 1679 were confirmed as MB (416 ICB, 1086 GIB, and 177 ECB). The free text‐based semi‐automatic algorithm had moderate recall (0.59), but high specificity (0.99), and precision (0.94). Conclusion The combination of hospitalization and critical localization is a valid approach to validate MB in EHRs with incomplete information. The use of more automatic methods for case validation instead of manual review of clinical notes is favored.
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