ABSTRACT
Introduction (contexte de la recherche): Erythema nodosum (EN) is a type IV delayed hypersensitivity reaction to a variety of antigens stimuli. In fact, EN is commonly caused by a range of conditions, including infections and vaccines. EN induced by COVID-19 vaccines is rarely reported. Objectif: Herein, we report an original clinical observation of EN occurring after the first dose of AstraZeneca COVID-19 vaccine (vaxzevria), a viral vector vaccine, without recurrence after the second dose. Methodes: This case was notified on August 2021 to Tunisian National Centre of Pharmacovigilance and was analyzed according to the French updated method for the causality assessment of adverse drug reactions. Resultats: A 46-year-old woman with no medical history, presented with diffuse erythematous painful and nodular lesions, located symmetrically over her legs. Eleven days before, she had received the first dose of vaxzevria which was followed by a sudden asthenia, and oedema over her lower limbs. The patient reported no recent infectious episodes. She had no known drug allergy. Skin examination showed multiple, tender, erythematous nodules, which ranged from 3 to 4 cm in diameter located over the tibial area. Some were regressive according to biligenesis shades. Laboratory tests including a complete blood count, renal and hepatic tests and antistreptolysin O titer were carried out and were negative except an elevated c-reactive protein of 45 mg/dL. The dermatological examination found lesions on both legs to be consistent with EN and started therapy with prednisone 40 mg daily for one week, subsequently gradually tapered and suspended, with complete regression of lower limb skin lesions within 10 days. No skin biopsy was performed due to the typical clinical presentation, color evolution and a complete response to steroid therapy. The patient subsequently received the second dose after two months without the reappearance of EN. Conclusion(s): In this case the role of vaccine was suspected in front of a temporal association between the first dose of vaccine and the onset of EN and the absence of another etiology. However, the good evolution of this skin manifestation will help reassure patients in the safety of vaccine administration.Copyright © 2023
ABSTRACT
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.
ABSTRACT
Introduction: COVID 19 vaccines are considered as an important medical advance in healthcare. It is the most promising approach for curbing the COVID-19 pandemic. However, as the number of people receiving vaccination rises, we are inevitably faced with increasing adverse drug reactions. The most common adverse reactions to vaccines are non-allergic, as flu like-symptoms and injection site reactions. Immediate hypersensitivity reactions are fortunately rare [1,2]. Objective(s): The aim of our work was to study clinical characteristics of acute urticaria following COVID-19 vaccines reported to the Tunisian National Center of Pharmacovigilance. Method(s): We conducted a retrospective study involving all cases of acute urticaria related to COVID-19 vaccines since the onset of the vaccine campaign in March 2021 to May 2022. Result(s): This study included 70 patients. Age ranged from 15 to 77 years old with a median age of 26 years. There were 51 women, and the sex ratio M/F was 0.37. The onset of urticaria varied from few hours to 17 days following vaccine injection with an average delay of 4 days. In 56 cases, urticaria occurred following 1st shot, in 10 cases following the 2nd dose and one case was reported following the 3rd dose of vaccine. This data was not mentioned in 3 cases. Outcome was favorable in 57 cases and unknown in 13 cases. Involved vaccines were Pfizer/BioNTech (47.14%), SPIKEVAX COVID-19 Vaccine Moderna (20%), AstraZeneca COVID-19 vaccine (15.71%), COVID-19 Vaccine Janssen (11.42%), CORONAVAC SINOVAC COVID-19 VACCINE (2.85%) and Sputnik V (2.85%). Urticaria was isolated in 58 cases, was associated with angioedema in 7 cases, and with fever in 5 cases. Conclusion(s): Our work showed a very low number of cases of acute urticaria following Covid-19 immunization. The Center for Disease Control and Prevention recommend, in patients who had even within 4 hours of getting vaccinated a non-severe allergic reaction to COVID-19 Vaccine to receive another dose of the same vaccine under medical surveillance. This is suggesting a non-specific mechanism.
ABSTRACT
Introduction: Dermatomyositis is an idiopathic autoimmune connective tissue disease. It is typically characterized by proximal muscle weakness and skin rashes. Dermatomyositis is associated with a higher risk of malignancy compared to the general population (1). One case in literature has reported a dermatomysitis post COVID-19 vaccination (2). Objective(s): Case report. Method(s): We report a case of dermatomyositis following Covid-19 immunization, notified to the National Centre of Pharmacovigilance of Tunis in May 2021. Result(s): A 33 year old woman, with no significant past medical history. She developed in March 2021, two days after 1st dose Pfizer BioNTeh Covid-19 vaccination, a mild facial erythema and ipsilateral auxiliary adenopathy. The evolution was marked by a persistence of the erythema and a regression of the adenopathy In April 2021, 2 days following the 2nd dose, she presented an accentuation of the symptomatology: skin erythema and edema in the photo-exposed areas: face, neck and upper limbs. As well as a diffuse myalgia in upper and lower limbs. She was afebrile and didn't present itchiness. The patient received intravenous methylprednisolone 1 injection per day for 5 days, followed by 1 mg/kg prednisolone and anti histaminic drugs without amelioration. The diagnosis of dermatomyositis was suspected in view of the persistence of the symptoms 1 month after vaccination and the installation of a proximal muscular deficit. Laboratory studies revealed a high level of creatine phosphokinase (CPK) at 3800 UI/l (<140) and Lactate dehydrogenase (LDH) at 628 UI/l (<248). The skin biopsy showed an aspect consistent with a moderate inflammatory myopathy. Autoimmune serology revealed the presence of anti-nuclear antibodies (ANA) (1/100) and a positive anti-Mi-2 antibodies. The patient underwent thorough malignancy screening. Findings of cervico-thoraco-abdomen pelvic scan didn't reveal any evidence for solid organ malignancies or interstitial lung disease. However, the mammogram and ultrasound-guided biopsy has identified an invasive carcinoma. Conclusion(s): This case showed a dermatomyositis case suspected initially to be associated to mRNA COVID vaccination which was finally related to a breast cancer.
ABSTRACT
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.
ABSTRACT
Introduction: COVID 19 vaccines are considered as an important medical advance in healthcare. It is the most promising approach for curbing the COVID-19 pandemic. However, as the number of people receiving vaccination rises, we are inevitably faced with increasing adverse drug reactions. The most common adverse reactions to vaccines are non-allergic, as flu like-symptoms and injection site reactions. Immediate hypersensitivity reactions are fortunately rare [1,2]. Objective: The aim of our work was to study clinical characteristics of acute urticaria following COVID-19 vaccines reported to the Tunisian National Center of Pharmacovigilance. Methods: We conducted a retrospective study involving all cases of acute urticaria related to COVID-19 vaccines since the onset of the vaccine campaign in March 2021 to May 2022. Results: This study included 70 patients. Age ranged from 15 to 77 years old with a median age of 26 years. There were 51 women, and the sex ratio M/F was 0.37. The onset of urticaria varied from few hours to 17 days following vaccine injection with an average delay of 4 days. In 56 cases, urticaria occurred following 1st shot, in 10 cases following the 2nd dose and one case was reported following the 3rd dose of vaccine. This data was not mentioned in 3 cases. Outcome was favorable in 57 cases and unknown in 13 cases. Involved vaccines were Pfizer/BioNTech (47.14%), SPIKEVAX COVID-19 Vaccine Moderna (20%), AstraZeneca COVID-19 vaccine (15.71%), COVID-19 Vaccine Janssen (11.42%), CORONAVAC SINOVAC COVID-19 VACCINE (2.85%) and Sputnik V (2.85%). Urticaria was isolated in 58 cases, was associated with angioedema in 7 cases, and with fever in 5 cases. Conclusion: Our work showed a very low number of cases of acute urticaria following Covid-19 immunization. The Center for Disease Control and Prevention recommend, in patients who had even within 4 hours of getting vaccinated a non-severe allergic reaction to COVID-19 Vaccine to receive another dose of the same vaccine under medical surveillance. This is suggesting a non-specific mechanism.
ABSTRACT
Introduction: Dermatomyositis is an idiopathic autoimmune connective tissue disease. It is typically characterized by proximal muscle weakness and skin rashes. Dermatomyositis is associated with a higher risk of malignancy compared to the general population (1). One case in literature has reported a dermatomysitis post COVID-19 vaccination (2). Objective: Case report. Methods: We report a case of dermatomyositis following Covid-19 immunization, notified to the National Centre of Pharmacovigilance of Tunis in May 2021. Results: A 33 year old woman, with no significant past medical history. She developed in March 2021, two days after 1st dose Pfizer BioNTeh Covid-19 vaccination, a mild facial erythema and ipsilateral auxiliary adenopathy. The evolution was marked by a persistence of the erythema and a regression of the adenopathy In April 2021, 2 days following the 2nd dose, she presented an accentuation of the symptomatology: skin erythema and edema in the photo-exposed areas: face, neck and upper limbs. As well as a diffuse myalgia in upper and lower limbs. She was afebrile and didn't present itchiness. The patient received intravenous methylprednisolone 1 injection per day for 5 days, followed by 1 mg/kg prednisolone and anti histaminic drugs without amelioration. The diagnosis of dermatomyositis was suspected in view of the persistence of the symptoms 1 month after vaccination and the installation of a proximal muscular deficit. Laboratory studies revealed a high level of creatine phosphokinase (CPK) at 3800 UI/l (< 140) and Lactate dehydrogenase (LDH) at 628 UI/l (< 248). The skin biopsy showed an aspect consistent with a moderate inflammatory myopathy. Autoimmune serology revealed the presence of anti-nuclear antibodies (ANA) (1/100) and a positive anti-Mi-2 antibodies. The patient underwent thorough malignancy screening. Findings of cervico-thoraco-abdomen pelvic scan didn't reveal any evidence for solid organ malignancies or interstitial lung disease. However, the mammogram and ultrasound-guided biopsy has identified an invasive carcinoma. Conclusion: This case showed a dermatomyositis case suspected initially to be associated to mRNA COVID vaccination which was finally related to a breast cancer.