Erythema nodosum following the first dose of AstraZeneca COVID-19 vaccine

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

Myocarditis following Coronavirus vaccination

Introduction: Myocarditis is an adverse reaction discovered after the marketing of SARS-CoV-2 mRNA vaccines. Nevertheless, this effect is not mentioned as an adverse reaction in the summary of product characteristics of other types of vaccines against this disease. Objective(s): In this work, we aim to present the cases of myocarditis after vaccination against COVID-19 reported to the national Tunisian centre of pharmacovigilance. Method(s): We present the cases of myocarditis reported after the COVID-19 vaccination. All cases are diagnosed according to Brighton's case definition of myocarditis. The vaccines causality assessment was estimated by the French imputability updated method of Begaud et al. Result(s): We included five patients. The sex ratio (M/F) was 4. The mean age was 30 years. All patients had no notable cardiovascular history and did not report any significant past medical history. The onset of symptoms was two days post-vaccination in three patients. The predominant reported symptoms are chest pain and dyspnea in the five cases. Cardiac magnetic resonance imaging (MRI) confirmed the myocarditis diagnosis in four patients (not performed for one patient). All cases were classified as definitive cases according to the Brighton case definition of myocarditis. No patient required hospitalization in a cardiac intensive care unit. All the patients recovered from acute myocarditis within a few days. Conclusion(s): Reported cases of myocarditis post-COVID-19 vaccination in our population are rare, not severe, and have a quick favorable outcome.Copyright © 2022

Follow-up of Covid-19 Vaccinated Pregnant and/or Breastfeeding Women in Tunisia

Introduction: Initially, vaccination against Covid-19 was not recommended during pregnancy due to the lack of data. With the benefit of hindsight, it has become recommended. This decision followed the reassuring results from pregnant women who voluntarily or inadvertently received Covid-19 vaccines, especially with mRNA vaccines [1]. In Tunisia, from May 2021, pregnant women have been prioritized in the national vaccination program with the recommendation of the messenger RNA platform. Objective(s): To follow-up Covid-19 vaccinated pregnant and/or breastfeeding women in Tunisia. Method(s): We have started a pilot study (from September 2021 to April 2022) for monitoring pregnant and/or breastfeeding women. Data collection was carried out via telephone calls. We excluded women who were unreachable after two phone calls. The data collected concerned the course as well as the outcome of the pregnancy and the health status of newborns. In addition, women were asked about the possible occurrence of adverse effects following immunization. Result(s): Our study included 1253 women. Seventeen percent of them were previously infected with Covid-19. The vaccination schedule was complete (two doses) in 83% of cases. Pfizer-BioNTech vaccine (PBV) was used in 73% of cases (11% of cases in the first trimester, 42% in the second trimester and 19% in the third trimester) and Moderna vaccine in 26%. Coronavac vaccine was used in 1% of cases. Vaccination was performed during pregnancy in 74 % of cases and breastfeeding in 11% of cases. Fifteen percent of women received the first dose during pregnancy and the second dose after childbirth. Reported adverse events following vaccination were: pain at the injection site in 47%, fever in 23%, soreness in 15%, asthenia in 6%, headache in 5%, hot flashes in 3% and chills in 1% of cases. Pregnancy and breastfeeding outcomes were favourable in 1246 women (99.4% of cases). Forty-seven percent of women delivered at term without incident and newborns were apparently in good health. One case of spontaneous miscarriage was reported in a woman with a history of spontaneous abortion and Covid-19 infection two weeks after receiving the first dose of PBV. Six cases of neonatal jaundice were also reported with PBV with good evolution with phototherapy. Conclusion(s): Our study confirms the data in the literature concerning the safety of Covid-19 vaccines on pregnant and/or breastfeeding women.

Acute Angle Closure Glaucoma Following COVID-19 Vaccination

Introduction: Although vaccines against COVID-19 are strongly recommended as safe and effective at alleviating the morbidity and mortality, different types of ocular complications have been reported after COVID-19 vaccination, including oculomotor nerve palsy, episcleritis, anterior uveitis, multifocal choroiditis, reactivation of Vogt-Koyanagi-Harada disease, acute macular neuroretinopathy and central serous retinopathy(1).Acute angle closure glaucoma (AACG) is an ophthalmic emergency that can be drug induced. If not promptly identified and treated, it can cause irreversible blindness. Objective(s): To describe an exceptional case of bilateral AACG that occurred within 4 hours following COVID-19 vaccination. Method(s): This case was notified to the pharmacovigilance department in February 2022. Result(s): A 38-year-old woman with a history of high myopia experienced stabbing pain in her left eye 4 hours after she received the second recombinant mRNA vaccine (Pfizer)injection. Few hours later, periorbital headache appeared in left side and the eye pain became much more severe. She took paracetamol by self-medication and stayed in the darkness. The following morning, she complained of sudden loss of vision in both eyes. She consulted an ophtalmologist, where elevated intraocular pressure (IOP) was noted in her left eye (60mm of mercury). Visual acuity examination showed results of 0.5 and 0.3 for right and left eyes, respectively. Goldman visual field test revealed a nasal field defect in her left eye. The angles of both eyes were closed on optical coherence tomography. Anterior segment examination demonstrated areflexic mydriasis. The patient was diagnosed with bilateral AACG. Topical instillation of pilocarpine was provided and the IOP decreased to 45 mm Hg in left eye. Then, the patient was prescribed systemic acetazolamide, and a fixed combination of bimatoprost-timolol. On follow-up after 24 hours, IOP improved to 19, 5 mm Hg in left eye and 11 mm Hg in right eye, however, the decreased vision persisted. Bilateral peripheral iridotomy was performed 10 days later. Two months after onset, the visual acuity was completely restored but the areflexic mydriasis was permanent. There was no recurrence of her glaucoma during a 3-month follow-up period. Conclusion(s): To the best of our knowledge, this is the first case to describe AACG following COVID-19 vaccination. The onset of ocular symptoms suggests a possible correlation between this complication and COVID-19 vaccination. However, the presence of other risk factors mainly high myopia puts this cause and effect relationship into question.

Do Patients with SARS-CoV-2 Vaccine-Induced Chronic Urticaria Can Have Their Second Dose?

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].

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.

COVID-19 Vaccination Errors During Tunisian Vaccination Campaign Collected from March 13, 2021 to September 29, 2021

Introduction: SinceMarch 13, 2021, Tunisia has started its vaccination campaign. In addition, the Ministry of Health has organized national mass vaccination days to accelerate the vaccination process. The National Centre of Pharmacovigilance, in collaborationwith the Primary Health CareDirection, is chargedwithmonitoring and managing adverse events following immunization (AEFI) that included vaccination errors. Objective(s): Our work aims to describe the type and the frequency of these errors in order to prevent their occurrence. Method(s): We conducted an observational study from the onset of the vaccination campaign on March 13, 2021, to September 29, 2021. We collected vaccine errors through the different notification sources used by the National Centre of Pharmacovigilance in Tunisia. We have listed vaccine errors through Vigibase national reports. We categorized the error reports on the basis of the vaccine error type described by the Centres for Disease Control and Prevention (CDC). Result(s): During this period, a total of 8.031297 doses were administered. We counted 153 COVID-19 vaccine errors out of 2609 AEFI (5.86%). Reports were related to wrong doses in 70% (Table 1). Conclusion(s): Most vaccination misuses are related to technical errors. The enhanced pharmacovigilance reporting system is important for detecting and managing these errors to prevent recurrence during further vaccination campaigns [1]. Moreover, health care providers involved in the COVID-19 vaccine supply chain should anticipate and report COVID-19 vaccine-related errors to promote shared learning opportunities and make every dose of vaccine count.

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).

Cytolytic Hepatitis Following mRNA Vaccination

Introduction: A few months after the commercialization of the COVID-19 mRNA vaccine, published case reports started to openeyed concerns about patients who presented autoimmune hepatitis (AIH) after receiving a COVID-19 vaccine [1-3]. Objective(s): We aim to describe cytolytic hepatitis following administration of the COVID-19 mRNA vaccine. Method(s): We report a case of cytolytic hepatitis following administration of the COVID-19 mRNA vaccine notified to the National Center of Pharmacovigilance. Result(s): A 37-year-old man with no notable medical history was incidentally diagnosed with cytolytic hepatitis during his preoperative lab tests for acute appendicitis. Liver transaminases were thrice the upper limit. He had received his two doses of mRNA vaccine Moderna two months before getting his lab tests. His serum immunoglobulins G, A, and M levels were within the normal range, and his immune lab tests were normal. Hepatitis serologies were negative. The abdominal ultrasound didn't demonstrate any abnormalities. The liver biopsy has revealed chronic active hepatitis lesions classified as F1A2. The patient had recovered spontaneously and had a normal liver transaminase level within 10 days. This case was scored I3 according to the french imputability updated method. Conclusion(s): Hepatitis following COVID-19 vaccination is an uncommon condition. Even if causality is still not proven clinicians must be vigilant for liver injuries in patients who have received COVID-19 vaccination.

Myocarditis Following SARS-CoV-2 Vaccines: A Series of Six Cases

Introduction: Myocarditis was observed after the commercialization of mRNA vaccines and was not initially described in the safety data of these vaccines [1,2]. Lately, it was considered an adverse effect of mRNA vaccines and mentioned in the summary of product characteristics. Objective(s): In this work, we aim to present the cases of myocarditis after SARS-CoV-2 vaccination reported during the vaccination campaign. Method(s): We present the cases of myocarditis reported to the pharmacovigilance national center after the SARS-CoV-2 vaccination. Data were collected retrospectively. All cases were defined according to Brighton's case definition of myocarditis. The vaccine causality assessment was estimated by the French imputability updated method of Begaud et al. [3]. Result(s): A total of six patients were included in this study. The sex ratio (M/F) was 0.5. The mean age was 31 years ranging from 18 to 41 years. All patients had no notable cardiovascular history and did not report any significant past medical history. The mean onset delay was 10 days post-vaccination. The predominant reported symptoms are chest pain and dyspnea in the six cases. Five patients have received an mRNA vaccine and one patient a viral vector vaccine. Cardiac magnetic resonance imaging confirmed the myocarditis diagnosis in five patients (not performed for one patient). All patients presented a troponin serum level elevation. The ejection fraction was reduced for five patients and conserved for one patient. All cases were classified as definitive cases according to the Brighton case definition of myocarditis. One patient required hospitalization in a cardiac intensive care unit. All the patients have recovered from acute myocarditis within a few days. Five cases were scored I2 and one case I1 according to the French updated imputability method. Conclusion(s): Reported cases of myocarditis post-SARS-CoV-2 vaccination are rare, generally not severe, and have a quick favorable outcome. Currently, causal relationships have been demonstrated with mRNA vaccines only.

Herpes-Zoster Reactivation Following SARS-CoV-2 Vaccines

Introduction: Recently, due to the massive administration of SARSCoV- 2 vaccines to a large population, a series of adverse events have been observed after its commercialization [1]. Post-marketing, sporadic case reports and series of Herpes Zoster reactivation were reported [2,3]. These cases constitute a potential signal. Objective(s): In this study, we aim to present a series of patients with Herpes-Zoster (HZ) reactivation following SARS-CoV-2 vaccination. Method(s): This is a retrospective study of HZ cases, reported to the National Centre of pharmacovigilance (CNPV) following SARSCoV- 2 vaccination from March 2021 to May 2022. Result(s): We included 20 patients;19 patients presented shingle and one patient had varicella. The sex ratio (M/F) was 0.8. The median age was 68.5 years. Nine patients were aged 70 years or older. The administered vaccine was an mRNA vaccine in 15/20 cases. The mean onset delay was 4.5 days. There was no concomitant use of immunosuppressants. All patients have recovered within a few days and no severe cases were reported. Two patients received the second dose, without recurrence of the symptomatology in one case. In the second case, there was an aggravation of the symptomatology and occurrence of facial paralysis;noting that the initial symptomatology was not entirely disappeared when the patient received the second dose. Conclusion(s): Our study does not establish causality but draws attention to a chronological association between the SARS-CoV-2 vaccine and HZ reactivation, which have to be investigated.

Pharmacovigilance Contribution During National Mass Immunization Days

Introduction: Rapid vaccination rollout against COVID-19 is the current main solution to overcome the pandemic morbidity and mortality but also to restart economies [1]. In Tunisia, 8 mass vaccination days have reinforced the national strategy. During these days, pharmacovigilance provided a real time monitoring regarding therapeutic advices and Adverse Events Following Immunizations (AEFIs). Objective(s): The objective of this study is to describe pharmacovigilance activities during these days. Method(s): This is a descriptive study. The reporting system was a combination of both passive and active surveillance. Notifications concerned therapeutic advices and adverse events following immunization (AEFI). Result(s): We collected 855 reports among 3,423,884 vaccinated people during these 08-mass vaccination days, corresponding to an average of 25 reports per 100,000 administrated doses. Reports of 720 AEFI's were collected: 268 (37.2%) were collected from the passive monitoring and 313 (43.4%) from the active surveillance. The passive surveillance reported 80% of vasovagal reaction, 19,3% vaccine errors and others notifications concerned cutaneous eruption, face swelling Vaccine errors (139) which occurred in 63.1% of cases during the 3rd National immunization day, concerned dilution errors, a double dose administration or errors in the vaccination pattern. AEFIs active monitoring revealed vasovagal reactions in 96.8% of cases, an elevated blood pressure, cutaneous eruption.. The Pharmacovigilance team managed 135 therapeutic advices concerning history of drug reaction, previous vaccine reaction, comorbidities Conclusion(s): The specificity of these immunization days was the increase of vasovagal cases and vaccination errors. Therefore, health authorities should deploy necessary means to prevent avoidable AEFIS during mass vaccination days.

Cerebro-Vascular Accident after Covid-19 Vaccination

Introduction: Stroke is the second cause of death and a major cause of disability worldwide. Its incidence is increasing related to the increase in the age of the population [1]. Younger people can be affected especially when they have risk factors (hypertension, diabetes, dyslipidemia, smoking or obesity) [2]. Objective(s): The aim of this study was to describe all the cases of Cerebral Vascular accident that occurred after Covid-19 immunization. Method(s): We conducted a retrospective study involving all cases of cerebral vascular accident 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 36 cases of Cerebral Vascular accident over 12 million doses of vaccine. These cases represented 1.2% of all the Adverse Effects following Immunization (AEFI) notified to the pharmacovigilance center. These cases were notified by attending physicians in 45.6% of cases. The sex ratio M/F was 3.2. The mean age was 73.4 years [51-87 years]. The onset of neurological symptoms ranged between 1 and 34 days with an average of 6,18 days following immunization. The cerebral vascular accident occurred after the 1st shot in 19 patients and after the 2nd shot for 7 patients. This data was not available for 10 patients. The involved vaccines were Pfizer/BioNTech (mRNA vaccine) in 63.8% cases, an adenovirus viral vector in 22.2% (AstraZeneca COVID-19 vaccine in 19.4% and Sputnik V in 2.8%), an inactivated Covid 19 vaccine in 11.1% cases (Coronavac 8.3% and Sinopharm 2.7%) Investigations revealed that 25 patients (69.4%) had at least one cardiovascular risk factors, 11 patients had at least 2 and 6 patients had 3 or more factors. Four patients had a cerebral vascular accident history. Hypertension was noticed in 15 patients, diabetes in 12 patients, dyslipidemia in 3 patients, cardiac rhythm disorders in 4 patients and a concomitant Covid-19 infection in 2 patients. For the other 11 patients, this data was not provided. There were no cases of Thrombosis with Thrombocytopenia Syndrome in our survey. Conclusion(s): Despite a temporal relationship, the vaccine responsibility cannot be retained given the patient's medical histories and the existence of several risk factors.

Urticaria Reactions after COVID-19 Vaccination: A Case Series

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.

Dermatomyositis Following Pfizer BioNTeh Covid-19 Vaccination

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.

Vogt-Koyanagi-Harada Uveitis Following Covid-19 Vaccine

Introduction: Vogt-Koyanagi-Harada (VKH) syndrome is a multisystem condition with chronic, bilateral, non-necrotizing, granulomatous panuveitis and exudative retinal detachment (1). It is a very rare adverse event of vaccination, and cases of VKH disease following Covid-19 vaccine have rarely been reported so far [1-3]. Objective(s): Herein, we report a case of VKH disease following mRNA-1273 (SpikeVax-) COVID-19 vaccination. Method(s): This case was notified in November 2021 to the National Centre of Pharmacovigilance and evaluated according to the updated French method of causality assessment. Result(s): A 33-year-old female patient with a medical history of renal failure and without any history of ophthalmic disease, received her second dose of SpikeVax on August 20, 2021. Four days later, she experienced headache and fatigue and subsequently developed bilateral blurred vision seven days following the vaccination. The evolution was marked by the persistence of symptoms and a decreased bilateral visual acuity a week later. Ophthalmologic examination showed an aqueous flare, keratic precipitates, iris nodules and cells in the anterior vitreous in both eyes work up ruled out systemic infection or autoimmune disease. ANCA were negative. ACE levels were normal. Serology test for HBV, HIV, syphilis and mycobacterium tuberculosis were also negative. A VKH syndrome was diagnosed. One month after treatment with oral prednisolone and mycophenolate mofetil, the evolution was favorable without any sequels. Conclusion(s): Although there is a chronological relation between the onset of VKH and the SpikeVax-, the role of vaccination couldn't be certainly assessed.

Cases of Guillan Barre Syndrome Following COVID-19 Vaccination

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.

COVID Vaccines AEFI Monitoring in Tunisia: March 2021 to May 2022

Introduction: As part of vaccines surveillance, a reinforced surveillance strategy for Covid-19 vaccines adverse events following immunization (AEFI) was set up in Tunisia. This strategy was conducted since the Covid-19 vaccination campaign has been started in March 2021. The safety profile of available vaccines was monitored in real time to ensure security of the population and to be able to anticipate coincidental events that might be attributed to the vaccine. Objective(s): to analyze the reported AEFI associated with different types of COVID-19 vaccines. Method(s): A descriptive study on AEFI from Covid-19 vaccines collected at the National Chalbi Belkahia Center for Pharmacovigilance (CNPV) from March 13th 2021 to May 22, 2022. During this period, vaccines used were Pfizer BioNTech, Vaxzevria, Spikevax , Janssen, Sputnik V, Coronavac, and Sinopharm. Result(s): We collected 3116 AEFI on 13 173 137 COVID-19 vaccines administered doses (0.02%). The mean age was 48.8 years [13-98]. The sex ratio M/F was 0.59. The vaccines mainly used were the Pfizer BioNTech vaccine in 51.6%, Vaxzevria in 16.1%, Spikevax in 10.9% and Janssen in 7.6% of cases. AEFI SOCs were general manifestations and injection site reactions (44%), nervous system disorders (27.4%), musculoskeletal and connective tissue disorders (16.4%), Skin and subcutaneous tissue disorders (16.2%), gastrointestinal disorders (12.1%), respiratory, thoracic and mediastinal disorders (6.7%), immune system disorders (5.9%), vascular disorders (5.8%), infections and infestations (5.7%), Injury, poisoning and procedural complications (5.5%), Ear and labyrinth disorders (4.9%), cardiac disorders (4.6%), and others (9.2%). The most reported MedDRA terms were fever (20.2%), asthenia (16.9%), headache (13.8%), injection site pain (9.4%), and muscle pain (8.9%). Serious AEFI were noted in 7% of AEFI. SOCs were Nervous system disorders (38.7%), Cardiac disorders (17.5%), General disorders and administration site conditions (15.2%), vascular disorders (12.9%), Infections and infestations (12.4%), Respiratory, thoracic and mediastinal disorders (7.8%), Skin and subcutaneous tissue disorders (6.5%), and others (21.2%). The most used vaccines in serious AEFI Pfizer BioNTech in 47%, Vaxzevria in 21.2% and Coronavac in 11.1%. Conclusion(s): This study confirms clinical trials data in which the most frequent AEFIs were general and injection site disorders. Serious adverse event were rare. These results show that the benefit of vaccination outweighs the risk and encourage vaccination.

Follow-up of Covid-19 Vaccinated Pregnant and/or Breastfeeding Women in Tunisia: An International Journal of Medical Toxicology and Drug Experience

Introduction: Initially, vaccination against Covid-19 was not recommended during pregnancy due to the lack of data. With the benefit of hindsight, it has become recommended. This decision followed the reassuring results from pregnant women who voluntarily or inadvertently received Covid-19 vaccines, especially with mRNA vaccines [1]. In Tunisia, from May 2021, pregnant women have been prioritized in the national vaccination program with the recommendation of the messenger RNA platform. Objective: To follow-up Covid-19 vaccinated pregnant and/or breastfeeding women in Tunisia. Methods: We have started a pilot study (from September 2021 to April 2022) for monitoring pregnant and/or breastfeeding women. Data collection was carried out via telephone calls. We excluded women who were unreachable after two phone calls. The data collected concerned the course as well as the outcome of the pregnancy and the health status of newborns. In addition, women were asked about the possible occurrence of adverse effects following immunization. Results: Our study included 1253 women. Seventeen percent of them were previously infected with Covid-19. The vaccination schedule was complete (two doses) in 83% of cases. Pfizer-BioNTech vaccine (PBV) was used in 73% of cases (11% of cases in the first trimester, 42% in the second trimester and 19% in the third trimester) and Moderna vaccine in 26%. Coronavac vaccine was used in 1% of cases. Vaccination was performed during pregnancy in 74 % of cases and breastfeeding in 11% of cases. Fifteen percent of women received the first dose during pregnancy and the second dose after childbirth. Reported adverse events following vaccination were: pain at the injection site in 47%, fever in 23%, soreness in 15%, asthenia in 6%, headache in 5%, hot flashes in 3% and chills in 1% of cases. Pregnancy and breastfeeding outcomes were favourable in 1246 women (99.4% of cases). Forty-seven percent of women delivered at term without incident and newborns were apparently in good health. One case of spontaneous miscarriage was reported in a woman with a history of spontaneous abortion and Covid-19 infection two weeks after receiving the first dose of PBV. Six cases of neonatal jaundice were also reported with PBV with good evolution with phototherapy. Conclusion: Our study confirms the data in the literature concerning the safety of Covid-19 vaccines on pregnant and/or breastfeeding women.

Acute Angle Closure Glaucoma Following COVID-19 Vaccination: An International Journal of Medical Toxicology and Drug Experience

Introduction: Although vaccines against COVID-19 are strongly recommended as safe and effective at alleviating the morbidity and mortality, different types of ocular complications have been reported after COVID-19 vaccination, including oculomotor nerve palsy, episcleritis, anterior uveitis, multifocal choroiditis, reactivation of Vogt-Koyanagi-Harada disease, acute macular neuroretinopathy and central serous retinopathy(1).Acute angle closure glaucoma (AACG) is an ophthalmic emergency that can be drug induced. If not promptly identified and treated, it can cause irreversible blindness.