ACCESS: Background rates of AESI to monitor vaccine safety- definition Acute disseminated encephalomyelitis

Sturkenboom, Mcjm; Willame, C; Durán, C; Engelen, R; Belbachir, L

doi:10.5281/zenodo.5109555

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“…The list of 29 AESIs comprised in alphabetical order: acute aseptic arthritis [29], acute coronary artery disease [30], acute disseminated encephalomyelitis (ADEM) [31], acute kidney injury [32], acute liver injury [33], acute respiratory distress syndrome [34], anaphylaxis [35], anosmia or ageusia [36], arrhythmia [37], Bells' palsy, chilblain-like lesions [38], death (defined as date of death in persons table), erythema multiforme [39], Guillain Barré Syndrome (GBS) [40], generalized convulsion[41], haemorrhagic stroke [42], heart failure [43], ischemic stroke [42], meningoencephalitis [44], microangiopathy [45], multisystem inflammatory syndrome [46], myo/pericarditis [47], myocarditis [47], narcolepsy [48], single organ cutaneous vasculitis (SOCV) [49], stress cardiomyopathy [50], thrombocytopenia [51], thrombotic thrombocytopenia syndrome (defined as arterial or venous thrombotic events & thrombocytopenia within 10 days) [42], venous thromboembolism (VTE) [42]. Sudden death and diabetes mellitus 1, which were in the protocol could not be studied adequately without further validation of algorithms and are not included in this publication.…”

Section: Adverse Events Of Special Interest (Aesi)mentioning

confidence: 99%

Cohort monitoring of 29 Adverse Events of Special Interest prior to and after COVID-19 vaccination in four large European electronic healthcare data sources

Sturkenboom

Messina

Paoletti

et al. 2022

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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.

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