ABSTRACT
Introduction: Adverse skin reactions, either immediate or delayed, were reported following COVID-19 vaccines [1]. Chronic spontaneous urticaria (CSU), a persisting urticaria beyond six weeks, has been rarely reported. These skin conditions present the challenge of the possibility of taking or not of the second dose and also its nature. Objective(s): To report cases of CSU after receiving vaccination against SARS-CoV-2 and the outcome after taking their second dose. Method(s): We performed a research on the database of the pharmacovigilance center from March 2021 to March 2022 using the keywords: urticaria, covid vaccine. The inclusion criteria were - persisting urticaria beyond six weeks after immunization - no urticaria prior the immunization during at least one month - second dose taken Non inclusion criteria were: - CSU not related to the vaccine Results: We retained three cases of CSU following COVID19 vaccine with second dose. There were two women and one man. Their age varied from 24 to 48 years. Two patients had chronic disease: one presented dysthyroidism, and the other presented asthma. The delay of occurrence of CSU varied from few hours to five days. The CSU in the three cases was not associated with other symptoms such as angioedema or dyspnea. In the three cases, the use of antihistamine drugs was only effective in reducing pruritus without complete release of urticaria. Follow up of the patients showed that they had their second dose after a period that varied between one and six months. They took their second dose while they continue to present urticaria. In the three patients, there was no exacerbation or specific complications. Conclusion(s): Our study showed that the administration of the second dose in patients that developed CSU after the previous vaccine can be considered safe and is advisable. Most of cases of exacerbation or worsening of CSU reported in the literature appear to be transient and can be managed by antihistamine therapies [2].
ABSTRACT
Introduction: Psoriasis is a chronic, immunologically mediated, inflammatory skin condition. It is characterized by well-defined, erythematous, indurated scaly plaques, with predilection of extensor surfaces, the scalp and the nails. It may be caused by drug, infection, stress, physical trauma, and vaccination. COVID 19 vaccines have recently been linked to worsening of pre-existing psoriasis. Objective(s): We report an exceptional case of new onset of psoriasis following COVID-19 vaccine. Method(s): This case was reported in February 2022 to The National Centre of Pharmacovigilance and evaluated according to the updated French method of causality assessment. Result(s): A 58-year-old female patient with a past medical history of hypothyroidism treated by sodiclevothyroxin received on 07 August 2021 her first dose of VAXZEVERIA COVID-19vaccine. On 17 August 2021, she presented to the emergency department because of anerythematous and febrile eruption on her limbs. Dermatological examination, revealed, erythematous skin with yellow crusts on the limbs and desquamation over the upper and lower limbs. No mucosal membrane or palmo-plantar involvement was noted. The bacterial skin swab was negative. Histological findings confirmed the Psoriasis. Based on the history and clinical findings, she was diagnosed with psoriasis onset with the vaccine. The patient was started on betametasone an calcipotriol resulting in a significant resolution of the skin eruption one month later. Conclusion(s): In this case, the responsibility of the COVID-19 vaccine in inducing Psoriasis was evaluated as I4 (C2S2) according to the updated French method of imputation in front of: a suggestive delay (10 days after starting the treatment), mainly the favorable outcome after the vaccination and the finding of skin biopsy. The responsibility of sodic levothyroxin was non retained because of the favorable outcome despite his pursuit. Psoriasis associated with COVID-19 vaccine is a rare condition.
ABSTRACT
Introduction: Guillain-Barre Syndrome (GBS) is a rare immune system disorder that results in muscle weakness, pain or numbness, and, in severe cases, paralysis. GBS is usually due to infections, and occurs more frequently in males and persons over 50 years old [1]. Some cases were described following vaccination among them COVID-19 vaccines. Objective(s): To describe features of COVID-19 vaccine-associated GBS. Method(s): We carried out a retrospective, descriptive study of GBS patients following COVID-19 vaccine, submitted to the World Health Organization (WHO) global adverse drug reaction database (VigiBase-) from Tunisia during the period between march 2021 and May 2022. We extracted the data using VigiLyze software with the English version 25 of MedDRA to identify features of COVID-19 vaccine-associated GBS. In addition, we evaluated vaccine causality using the updated French causality assessment method [2]. Result(s): Overall, we retrieved 8 patients with GBS post COVID-19 vaccination: Men were representing 62.5% (5/3) of cases. The median age of affected patients was 59 (range: 41;80) years. The most frequently reported vaccine type was followed in order by Comirnaty Pfizer-BioNTech vaccine (n = 3 reports [37.5%]), Vaxzevria AstraZeneca vaccine (n = 3 [37.5%]) and Janssen vaccine (n = 2 [25%]). The mean time interval from vaccination to symptom onset was 15.3 days (range 7-30 days). Four patients developed GBS after receiving the first dose of a COVID-19 vaccine, three after the second dose and one after the third dose. Clinical manifestations were different with varying severity: classical GBS [1] (progressive ascending limb weakness associated with reduced or absent reflexes) in 5 cases, and GBS with unilateral facial palsy in 3. In all cases, electromyography (EMG) studies were consistent with the demyelinating pathology of GBS. Cerebrospinal fluid (CSF) examination showed albuminocytologic dissociation in 3 cases, was normal in 3 and not done in 2. Five patients were treated with a course of intravenous immune globulin (IVIg) for five days and one patient received a total of 2 sessions of plasma exchange. In 2 patients the nature of the treatment was unknown. Six patients reported clinical improvement within 7-10 days while two showed treatment-related fluctuations (TRF). Conclusion(s): Our observations suggest that COVID-19 vaccines may be associated with GBS. Continuous surveillance and further studies are warranted to assess the significance of the association.
ABSTRACT
Introduction: Adverse skin reactions, either immediate or delayed, were reported following COVID-19 vaccines [1]. Chronic spontaneous urticaria (CSU), a persisting urticaria beyond six weeks, has been rarely reported. These skin conditions present the challenge of the possibility of taking or not of the second dose and also its nature. Objective: To report cases of CSU after receiving vaccination against SARS-CoV-2 and the outcome after taking their second dose. Methods: We performed a research on the database of the pharmacovigilance center from March 2021 to March 2022 using the keywords: urticaria, covid vaccine. The inclusion criteria were - persisting urticaria beyond six weeks after immunization - no urticaria prior the immunization during at least one month - second dose taken Non inclusion criteria were: - CSU not related to the vaccine Results: We retained three cases of CSU following COVID19 vaccine with second dose. There were two women and one man. Their age varied from 24 to 48 years. Two patients had chronic disease: one presented dysthyroidism, and the other presented asthma. The delay of occurrence of CSU varied from few hours to five days. The CSU in the three cases was not associated with other symptoms such as angioedema or dyspnea. In the three cases, the use of antihistamine drugs was only effective in reducing pruritus without complete release of urticaria. Follow up of the patients showed that they had their second dose after a period that varied between one and six months. They took their second dose while they continue to present urticaria. In the three patients, there was no exacerbation or specific complications. Conclusion: Our study showed that the administration of the second dose in patients that developed CSU after the previous vaccine can be considered safe and is advisable. Most of cases of exacerbation or worsening of CSU reported in the literature appear to be transient and can be managed by antihistamine therapies [2].
ABSTRACT
Introduction: Psoriasis is a chronic, immunologically mediated, inflammatory skin condition. It is characterized by well-defined, erythematous, indurated scaly plaques, with predilection of extensor surfaces, the scalp and the nails. It may be caused by drug, infection, stress, physical trauma, and vaccination. COVID 19 vaccines have recently been linked to worsening of pre-existing psoriasis. Objective: We report an exceptional case of new onset of psoriasis following COVID-19 vaccine. Methods: This case was reported in February 2022 to The National Centre of Pharmacovigilance and evaluated according to the updated French method of causality assessment. Results: A 58-year-old female patient with a past medical history of hypothyroidism treated by sodiclevothyroxin received on 07 August 2021 her first dose of VAXZEVERIA COVID-19vaccine. On 17 August 2021, she presented to the emergency department because of anerythematous and febrile eruption on her limbs. Dermatological examination, revealed, erythematous skin with yellow crusts on the limbs and desquamation over the upper and lower limbs. No mucosal membrane or palmo-plantar involvement was noted. The bacterial skin swab was negative. Histological findings confirmed the Psoriasis. Based on the history and clinical findings, she was diagnosed with psoriasis onset with the vaccine. The patient was started on betametasone an calcipotriol resulting in a significant resolution of the skin eruption one month later. Conclusion: In this case, the responsibility of the COVID-19 vaccine in inducing Psoriasis was evaluated as I4 (C2S2) according to the updated French method of imputation in front of: a suggestive delay (10 days after starting the treatment), mainly the favorable outcome after the vaccination and the finding of skin biopsy. The responsibility of sodic levothyroxin was non retained because of the favorable outcome despite his pursuit. Psoriasis associated with COVID-19 vaccine is a rare condition.
ABSTRACT
Introduction: Guillain-Barre Syndrome (GBS) is a rare immune system disorder that results in muscle weakness, pain or numbness, and, in severe cases, paralysis. GBS is usually due to infections, and occurs more frequently in males and persons over 50 years old [1]. Some cases were described following vaccination among them COVID-19 vaccines. Objective: To describe features of COVID-19 vaccine-associated GBS. Methods: We carried out a retrospective, descriptive study of GBS patients following COVID-19 vaccine, submitted to the World Health Organization (WHO) global adverse drug reaction database (VigiBase®) from Tunisia during the period between march 2021 and May 2022. We extracted the data using VigiLyze® software with the English version 25 of MedDRA to identify features of COVID-19 vaccine-associated GBS. In addition, we evaluated vaccine causality using the updated French causality assessment method [2]. Results: Overall, we retrieved 8 patients with GBS post COVID-19 vaccination: Men were representing 62.5% (5/3) of cases. The median age of affected patients was 59 (range: 41;80) years. The most fre- quently reported vaccine type was followed in order by Comirnaty® Pfizer-BioNTech vaccine (n = 3 reports [37.5%]), Vaxzevria® AstraZeneca vaccine (n = 3 [37.5%]) and Janssen® vaccine (n = 2 [25%]). The mean time interval from vaccination to symptom onset was 15.3 days (range 7-30 days). Four patients developed GBS after receiving the first dose of a COVID-19 vaccine, three after the second dose and one after the third dose. Clinical manifestations were dif- ferent with varying severity: classical GBS [1] (progressive ascending limb weakness associated with reduced or absent reflexes) in 5 cases, and GBS with unilateral facial palsy in 3. In all cases, electromyog- raphy (EMG) studies were consistent with the demyelinating pathology of GBS. Cerebrospinal fluid (CSF) examination showed albuminocytologic dissociation in 3 cases, was normal in 3 and not done in 2. Five patients were treated with a course of intravenous immune globulin (IVIg) for five days and one patient received a total of 2 sessions of plasma exchange. In 2 patients the nature of the treatment was unknown. Six patients reported clinical improvement within 7-10 days while two showed treatment-related fluctuations (TRF). Conclusion: Our observations suggest that COVID-19 vaccines may be associated with GBS. Continuous surveillance and further studies are warranted to assess the significance of the association.