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Evaluation of patients with antiphospholipid syndrome subsequently COVID-19 vaccinations: A retrospective cohort
Özlem Karakaş1, Abdulsamet Erden2, Berkan Armağan1
1Clinic of Rheumatology, Ankara City Hospital, Ankara, Turkey.
Insights
COVID-19 vaccination in antiphospholipid syndrome (APS) patients showed common side effects like myalgia and malaise. Importantly, no new thrombotic events or APS flares were observed after receiving CoronaVac or BNT162b2 vaccines.
Area of Science:
- Immunology
- Vaccinology
- Rheumatology
Background:
- Antiphospholipid syndrome (APS) is an autoimmune disorder increasing thrombotic risk.
- COVID-19 vaccines are crucial, but safety in APS patients requires specific evaluation.
Purpose of the Study:
- To assess side effects and complications following COVID-19 vaccination in APS patients.
- To investigate thrombotic or obstetric events post-vaccination in this cohort.
Main Methods:
- Retrospective cohort study of 35 APS patients vaccinated with CoronaVac and/or BNT162b2.
- Data collected via outpatient appointments and phone calls regarding adverse events.
- Evaluation of vaccine-related thrombotic events, APS flares, and obstetric complications.
Main Results:
- Most common adverse events were myalgia and malaise after both vaccines.
- No new vaccine-related thrombotic events or APS flares were observed.
- Reported adverse events in 45.0% of BNT162b2 recipients and 42.9% of CoronaVac recipients.
Conclusions:
- COVID-19 vaccination appears safe in APS patients regarding thrombotic events and disease flares.
- Common side effects like myalgia and malaise are manageable.
- Further large-scale studies are recommended for definitive conclusions on COVID-19 vaccine safety in APS.
Abstract:
The aim of this study is to evaluate development of side effects, thrombotic or obstetric complications in our antiphospholipid syndrome (APS) patient group, after vaccination against coronavirus disease 2019 (COVID-19). A cohort was formed from patients who have previously been followed up with a diagnosis of APS. The patients of the cohort were evaluated retrospectively to find out if they were vaccinated with CoronaVac and/or BNT162b2 vaccines which are being used in our country. To evaluate the side effects seen after the vaccination, the information was collected by the patients in their outpatient appointments or making a phone call. Thirty-five APS patients who had received at least 1 dose of any of the COVID-19 vaccines were included in the study. Median (min-max) number of vaccine doses per patient was 2 (1-3). Eleven patients had a booster dose after primary vaccination. Twenty patients were ever vaccinated with BNT162b2 and 18 with CoronaVac. Among BNT162b2 recipients, 9 (45.0%) and among CoronaVac recipients 15 (42.9%) reported an adverse event after a vaccine administration. The most common adverse events were myalgia and malaise after any dose of both vaccines. No vaccine-related new thrombotic events or APS flares were observed. Our results were comparable with those reported in the literature. Comprehensive large-scale studies are needed for more accurate results on the evaluation of side effects after COVID-19 vaccination in APS patients.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

