Thromboembolic Events and COVID-19 Vaccine

Introduction: Thromboembolic events (TE) are a major source of morbidity and mortality. Several risk factors have been associated to this condition such as age over 65 years, obesity, history of venous thromboembolism and hereditary thrombophilias [1]. Otherwise, TE have been associated with SARS-CoV-2 infection. Following the introduction of COVID-19 vaccines, these events were expected to decrease significantly [2]. However, some TE cases appeared after COVID-19 vaccination. Objective(s): The aim of this study was to summarize all the cases of TE that occurred after COVID-19 immunization in Tunisia. Method(s): We conducted a retrospective study involving all cases of TE that occurred after COVID-19 vaccination, from the beginning of the campaign of immunization in March 2021 to May 2022. These cases were notified to the National Center of Pharmacovigilance, Tunisia. Result(s): There were 25 cases of thrombotic events over about 12 million doses of vaccine. The mean age was 51.2+/-15,8 years. The sex ratio (M/F) was 1,27. Symptom onset occurred within 1 to 60 days. Both arterial and venous thrombotic events were reported. Venous thromboembolism was observed in 21 cases (84%). Deep vein thrombosis in 9 cases (36%), superficial vein thrombosis in 3 cases (12%), pulmonary embolism in 3 cases (12%) and the site of venous thrombosis was not specified in 6 cases (24%). Arteriel thromboembolism was reported in 4 patients: splenic infarction (1 case), thrombosis of the renal artery (1 case), thrombosis of the brachial artery (1 case) and femoral artery embolism (1 case). The TE were reported after the first shot in 72% of cases, after the second shot in 24% and after the third shot in one case (4%). The involved vaccines are summarized in table 1. Investigations revealed risk factors for TE in 12 patients. There were: age over 65 years in 25% of cases, thrombophilia in 25%, thromboembolic events histories in 25%, varicose vein thrombosis in 16.7% and immobilization in 8.3% of cases. This data was not provided for the 13 other patients. The outcome was favorable in 19 patients, one patient died and 5 patients were lost to follow up. There were no cases of Thrombotic Thrombocytopenia syndrome. Conclusion(s): Despite a temporal relationship, the vaccine responsibility cannot be retained given the patient's medical histories.

Fixed Drug Eruption after ChAdOx1 nCoV-19 Vaccine

Introduction: ChAdOx1 nCoV-19 vaccine is an adenoviral-vectored COVID-19 vaccine. The most common side effects are headache, muscle pain, redness, swelling, and tenderness at the injection site. Cutaneous reactions have been rarely reported. Objective(s): To discuss the association between a fixed drug eruption (FDE) and ChAdOx1 nCoV-19 vaccine. Method(s): We report one case of (FDE) following administration of the ChAdOx1 nCoV-19. Result(s): A 60-year-old man with no medical history and no regular medication presented with a rash that had appeared 24 hours after he had received his first dose of the ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca). The lesions had appeared abruptly without any accompanying symptoms. Physical examination revealed three, well-defined, round to oval, erythematous to violaceous plaques in the face. A punch biopsy was taken, and histopathology findings were consistent with fixed drug eruption. Conclusion(s): This case shows that the fixed drug eruption can be a result of receiving the ChAdOx1 nCoV-19 vaccine (Oxford- AstraZeneca).

Thromboembolic Events and COVID-19 Vaccine: An International Journal of Medical Toxicology and Drug Experience

Introduction: Thromboembolic events (TE) are a major source of morbidity and mortality. Several risk factors have been associated to this condition such as age over 65 years, obesity, history of venous thromboembolism and hereditary thrombophilias [1]. Otherwise, TE have been associated with SARS-CoV-2 infection. Following the introduction of COVID-19 vaccines, these events were expected to decrease significantly [2]. However, some TE cases appeared after COVID-19 vaccination. Objective: The aim of this study was to summarize all the cases of TE that occurred after COVID-19 immunization in Tunisia. Methods: We conducted a retrospective study involving all cases of TE that occurred after COVID-19 vaccination, from the beginning of the campaign of immunization in March 2021 to May 2022. These cases were notified to the National Center of Pharmacovigilance, Tunisia. Results: There were 25 cases of thrombotic events over about 12 million doses of vaccine. The mean age was 51.2±15,8 years. The sex ratio (M/F) was 1,27. Symptom onset occurred within 1 to 60 days. Both arterial and venous thrombotic events were reported. Venous thromboembolism was observed in 21 cases (84%). Deep vein thrombosis in 9 cases (36%), superficial vein thrombosis in 3 cases (12%), pulmonary embolism in 3 cases (12%) and the site of venous thrombosis was not specified in 6 cases (24%). Arteriel thromboembolism was reported in 4 patients: splenic infarction (1 case), thrombosis of the renal artery (1 case), thrombosis of the brachial artery (1 case) and femoral artery embolism (1 case). The TE were reported after the first shot in 72% of cases, after the second shot in 24% and after the third shot in one case (4%). The involved vaccines are summarized in table 1. Investigations revealed risk factors for TE in 12 patients. There were: age over 65 years in 25% of cases, thrombophilia in 25%, thromboembolic events histories in 25%, varicose vein thrombosis in 16.7% and immobilization in 8.3% of cases. This data was not provided for the 13 other patients. The outcome was favorable in 19 patients, one patient died and 5 patients were lost to follow up. There were no cases of Thrombotic Thrombocytopenia syndrome. Conclusion: Despite a temporal relationship, the vaccine responsibility cannot be retained given the patient's medical histories.

Fixed Drug Eruption after ChAdOx1 nCoV-19 Vaccine: An International Journal of Medical Toxicology and Drug Experience

Introduction: ChAdOx1 nCoV-19 vaccine is an adenoviral-vectored COVID-19 vaccine. The most common side effects are headache, muscle pain, redness, swelling, and tenderness at the injection site. Cutaneous reactions have been rarely reported. Objective: To discuss the association between a fixed drug eruption (FDE) and ChAdOx1 nCoV-19 vaccine. Methods: We report one case of (FDE) following administration of the ChAdOx1 nCoV-19. Results: A 60-year-old man with no medical history and no regular medication presented with a rash that had appeared 24 hours after he had received his first dose of the ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca). The lesions had appeared abruptly without any accompanying symptoms. Physical examination revealed three, well-defined, round to oval, erythematous to violaceous plaques in the face. A punch biopsy was taken, and histopathology findings were consistent with fixed drug eruption. Conclusion: This case shows that the fixed drug eruption can be a result of receiving the ChAdOx1 nCoV-19 vaccine (OxfordAstraZeneca).