scholarly journals Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study

BMJ ◽  
2021 ◽  
pp. n1931 ◽  
Author(s):  
Julia Hippisley-Cox ◽  
Martina Patone ◽  
Xue W Mei ◽  
Defne Saatci ◽  
Sharon Dixon ◽  
...  

Abstract Objective To assess the association between covid-19 vaccines and risk of thrombocytopenia and thromboembolic events in England among adults. Design Self-controlled case series study using national data on covid-19 vaccination and hospital admissions. Setting Patient level data were obtained for approximately 30 million people vaccinated in England between 1 December 2020 and 24 April 2021. Electronic health records were linked with death data from the Office for National Statistics, SARS-CoV-2 positive test data, and hospital admission data from the United Kingdom’s health service (NHS). Participants 29 121 633 people were vaccinated with first doses (19 608 008 with Oxford-AstraZeneca (ChAdOx1 nCoV-19) and 9 513 625 with Pfizer-BioNTech (BNT162b2 mRNA)) and 1 758 095 people had a positive SARS-CoV-2 test. People aged ≥16 years who had first doses of the ChAdOx1 nCoV-19 or BNT162b2 mRNA vaccines and any outcome of interest were included in the study. Main outcome measures The primary outcomes were hospital admission or death associated with thrombocytopenia, venous thromboembolism, and arterial thromboembolism within 28 days of three exposures: first dose of the ChAdOx1 nCoV-19 vaccine; first dose of the BNT162b2 mRNA vaccine; and a SARS-CoV-2 positive test. Secondary outcomes were subsets of the primary outcomes: cerebral venous sinus thrombosis (CVST), ischaemic stroke, myocardial infarction, and other rare arterial thrombotic events. Results The study found increased risk of thrombocytopenia after ChAdOx1 nCoV-19 vaccination (incidence rate ratio 1.33, 95% confidence interval 1.19 to 1.47 at 8-14 days) and after a positive SARS-CoV-2 test (5.27, 4.34 to 6.40 at 8-14 days); increased risk of venous thromboembolism after ChAdOx1 nCoV-19 vaccination (1.10, 1.02 to 1.18 at 8-14 days) and after SARS-CoV-2 infection (13.86, 12.76 to 15.05 at 8-14 days); and increased risk of arterial thromboembolism after BNT162b2 mRNA vaccination (1.06, 1.01 to 1.10 at 15-21 days) and after SARS-CoV-2 infection (2.02, 1.82 to 2.24 at 15-21 days). Secondary analyses found increased risk of CVST after ChAdOx1 nCoV-19 vaccination (4.01, 2.08 to 7.71 at 8-14 days), after BNT162b2 mRNA vaccination (3.58, 1.39 to 9.27 at 15-21 days), and after a positive SARS-CoV-2 test; increased risk of ischaemic stroke after BNT162b2 mRNA vaccination (1.12, 1.04 to 1.20 at 15-21 days) and after a positive SARS-CoV-2 test; and increased risk of other rare arterial thrombotic events after ChAdOx1 nCoV-19 vaccination (1.21, 1.02 to 1.43 at 8-14 days) and after a positive SARS-CoV-2 test. Conclusion Increased risks of haematological and vascular events that led to hospital admission or death were observed for short time intervals after first doses of the ChAdOx1 nCoV-19 and BNT162b2 mRNA vaccines. The risks of most of these events were substantially higher and more prolonged after SARS-CoV-2 infection than after vaccination in the same population.

2021 ◽  
Author(s):  
Martina Patone ◽  
Xue W. Mei ◽  
Lahiru Handunnetthi ◽  
Sharon Dixon ◽  
Francesco Zaccardi ◽  
...  

AbstractAlthough myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1–28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1–28 days postvaccination period, and after a SARS-CoV-2 positive test. We estimated an extra two (95% confidence interval (CI) 0, 3), one (95% CI 0, 2) and six (95% CI 2, 8) myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 (95% CI 38, 41) myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test. We also observed increased risks of pericarditis and cardiac arrhythmias following a positive SARS-CoV-2 test. Similar associations were not observed with any of the COVID-19 vaccines, apart from an increased risk of arrhythmia following a second dose of mRNA-1273. Subgroup analyses by age showed the increased risk of myocarditis associated with the two mRNA vaccines was present only in those younger than 40.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1086-1086
Author(s):  
Margaux Lafaurie ◽  
Bérangère Baricault ◽  
Maryse Lapeyre-Mestre ◽  
Laurent Sailler ◽  
Agnès Sommet ◽  
...  

Introduction: Epidemiological studies suggest a risk of immune thrombocytopenia (ITP) following viral infections, particularly influenza. Conversely, an increased risk of ITP following vaccination has been proven for some vaccines like Measles-Mumps-Rubella vaccine. However, the risk of ITP induced by influenza vaccine is debated. Two case-controls studies has been conducted, with contradictory results: in the Berlin Case-Control Surveillance Study, an increased risk has been found (odds ratio - OR: 3.8 [95% confidence interval - CI: 1.5- 9.1]. Conversely, the French PGRx study suggested the absence of risk of ITP after influenza vaccination [OR: 0.9; 95% CI: 0.4-2.1]. These studies were limited by the number of ITP patients included (169 and 198, respectively) and other limitations. Therefore, we aimed to assess the risk of ITP induced by influenza vaccine in a nationwide cohort in France. Methods: We conducted a population-based study in France within the FAITH cohort (NCT03429660). This cohort is built within the National Health Database that links sociodemographic, hospital and out-hospital data. The FAITH cohort includes all adult patients with incident ITP in France since 2009. Patients are identified using a validated algorithm combining diagnosis codes and drug exposures (with very high positive predictive values). We included in the present study all patients with incident primary ITP aged ≥65 years at ITP diagnosis (indication of influenza vaccination in the general population in France) between July 2009 and June 2015. We assessed the link between influenza vaccine and ITP onset using two designs: a case-control and a self-controlled case series designs. In the case-control design, ITP cases were matched with four controls from the general population for age, sex and place of residency. Index dates for controls were similar to index dates of their matched cases. Cases and controls were compared for exposure to influenza vaccine in the 6 weeks before the index date using conditional logistic regression models adjusted for exposure to other drugs known as inducers of ITP. In the self-controlled case series study, only vaccinated ITP cases were included. The analysis compared the incidence of ITP within periods of risk (6 weeks following vaccination) to the incidence of ITP within other periods of time. We further excluded the 2 weeks prior to vaccine dispensing from the analysis to address selective survival bias (healthy vaccinee effect). Incidence rate ratios (IRRs) adjusted for seasonality were calculated. Results: We included 3,142 incident primary ITP patients aged ≥65 years matched with 12,528 controls in the case-control study. Overall, 147 cases (4.7%) and 579 controls (4.6%) were vaccinated with influenza vaccine during the 6 weeks prior to the index date (adjusted OR: 0.99; 95% CI: 0.80-1.23]). In the self-controlled case series study, 1,875 vaccinated ITP cases were included. Among them, 146 (7.8%) patients were diagnosed for ITP during one of the risk periods following vaccination. The adjusted IRR was 0.96 [95 CI%: 0.80-1.17]. Conclusion: This nationwide population-based study using two different designs showed no increased risk of ITP after influenza vaccination. Disclosures Moulis: Novartis pharma: Research Funding, Speakers Bureau; Amgen pharma: Research Funding, Speakers Bureau; CSL Behring: Research Funding.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Nicole L. Pratt ◽  
Emmae N. Ramsay ◽  
Lisa M. Kalisch Ellett ◽  
Tuan A. Nguyen ◽  
Elizabeth E. Roughead

Introduction. Ophthalmic timolol, a topical nonselective beta-blocker, has the potential to be absorbed systemically which may cause adverse cardiovascular effects. This study was conducted to determine whether initiation of ophthalmic timolol was associated with an increased risk of hospitalisation for bradycardia.Materials and Methods. A self-controlled case-series study was undertaken in patients who were hospitalised for bradycardia and were exposed to timolol. Person-time after timolol initiation was partitioned into risk periods: 1–30 days, 31–180 days, and >180 days. A 30-day risk period prior to initiating timolol was also included. All remaining time was considered unexposed.Results. There were 6,373 patients with at least one hospitalisation for bradycardia during the study period; 267 were exposed to timolol. Risk of bradycardia was significantly increased in the 31–180 days after timolol initiation (incidence rate ratio (IRR) = 1.93; 95% confidence interval (CI) 1.00–1.87). No increased risk was observed in the first 30 days or beyond 180 days of continuous exposure (IRR = 1.40; 95% CI 0.87–2.26 and IRR = 1.21; 95% CI 0.64–2.31, resp.).Conclusion. Bradycardia is a potential adverse event following timolol initiation. Practitioners should consider patient history before choosing a glaucoma regime and closely monitor patients after treatment initiation with topical nonselective beta-blocker eye drops.


2021 ◽  
Vol 85 (3) ◽  
pp. 309-313
Author(s):  
Yugo Yamashita ◽  
Nobuhiro Hara ◽  
Masahiro Obana ◽  
Satoshi Ikeda ◽  
Motohiko Furuichi ◽  
...  

2017 ◽  
Vol 66 (2) ◽  
pp. 268-273 ◽  
Author(s):  
Anne-Marie Connolly-Andersen ◽  
Heather Whitaker ◽  
Jonas Klingström ◽  
Clas Ahlm

2017 ◽  
Vol 24 (07) ◽  
pp. 1016-1019
Author(s):  
Raheela Rani Junejo ◽  
Rabail Rani Junejo ◽  
Shahla Baloch ◽  
Raheel Sikandar ◽  
Mehrunnisa Khaskheli

Objectives: To determine the frequency of postpartum haemorrhage in obeseprimigravid women. Study Design: Case series study. Period: Six months was conductedfrom 1st October 2014 to 30 March 2015. Setting: Department of gynecology and obstetricsat Liaquat University Hospital Jamshoro. Patients and Methods: All the primigravid obese(≥30kg/m2) ladies 18 to 35 years of age with 37-42 weeks of gestational age were evaluate forthe occurrence of PPH by estimating blood loss of greater than 500 ml of blood following vaginaldelivery or 1000 ml of blood loss following caesarean section. All data was entered and analyzedthrough statistical package SPSS version 17, the chi-square statistical test was applied and thep-value ≤0.05 was considered as statistical significant. Results: Total 203 primigravid obeseladies were studies, the age group was analyzed which shows that in age group between 18-25years were 105(52.00%) women, in age group of 26-30 years were 62(30.69%) women and agegroup of 30 years and above were 35 (17.31%) women. The modes of delivery were evaluatedwhich shows that 66.5% women underwent C-section and 33.4% women had normal vaginaldelivery. The PPH was observed in 34.97% patients (70.4% with C-Section and 29.6 with NVD).Conclusion: Obesity carries a significant increased risk of complications during pregnancyand maternal risks during labour are PPH and more frequent C-section and nulliparous obesewomen have twofold high risk for PPH


Author(s):  
Frederick K Ho ◽  
Kenneth KS Man ◽  
Mark Toshner ◽  
Carlos Celis-Morales ◽  
Ian CK Wong ◽  
...  

AbstractImportanceAn unexpectedly large number of people infected with Covid-19 appear to have experienced ischaemic stroke or thrombotic event.ObjectiveThis study aims to assess the risk associations between Covid-19 infection and thromboembolism.DesignThis is a self-controlled case-series study in Scotland. Their incidence rates during the risk interval (5 days before to 56 days after the positive test) and the control interval (the remaining periods) were compared intra-personally.SettingPopulation-based.ParticipantsIndividuals with confirmed (positive test) Covid-19 and at least one thromboembolic event between March 2018 and October 2020.ExposureCovid-19 test positive.Main Outcomes and MeasuresMyocardial infarction (MI), ischaemic stroke, deep-vein thrombosis (DVT), and pulmonary embolism (PE) hospital admissions and deaths.ResultsAcross Scotland, 1,449 individuals tested positive for Covid-19 and experienced a thromboembolic event. The risk of thromboembolism was significantly elevated over the whole risk period but highest in the 7 days following the positive test (IRR 12.01, 95% CI 9.91-14.56), especially among people ≤75 years (IRR 22.78, 95% CI 17.58-29.53). Risk of MI, stroke, PE and DVT were all significantly higher in the week following a positive test. The risk of PE and DVT was particularly high and remained significantly elevated even 56 days following the test.Conclusions and relevanceConfirmed Covid-19 infection was associated with early elevated risk of MI, ischaemic stroke, and stronger and long elevations in risk with DVT and PE, reinforcing the need to consider monitoring and early diagnosis. Treatment and prevention trials may need to be considered out of hospital on the basis of risk stratification.Key PointsQuestionDoes Covid-19 infection increase the risk of thromboembolism?FindingsAmong 1,449 individuals in Scotland who were tested positive of Covid-19 and had at least one thromboembolic events, the risk of thromboembolism was significantly elevated in the 7 days following the positive test (IRR 12.01, 95% CI 9.91-14.56). The risk of PE and DVT was particularly high and remained significantly elevated even 56 days following the test.MeaningConfirmed Covid-19 infection was associated with early elevated risk of MI, ischaemic stroke, and stronger and long elevations in risk with DVT and PE, reinforcing the need to consider monitoring and early diagnosis.


Author(s):  
Amir Moeintaghavi ◽  
Negar Azami ◽  
Mohammad Sadegh Zohrevand ◽  
Farid Shiezadeh ◽  
Hamid Jafarzadeh ◽  
...  

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